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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
  • open for enrollment

    Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma

    Protocol: OSU-13244

    Eligibility:

    Inclusion Criteria:

    • Provided signed written informed consent
    • Males and females >=18 years of age (at the time consent is obtained).
    • Histologically or cytologically confirmed diagnosis of small cell lung carcinoma. Subjects must have measurable disease per RECIST 1.1 (for Part 2 only).
    • Recurrent or refractory disease after receiving at least one prior standard/approved platinum-containing chemotherapy regimen, or where standard therapy is refused. Part 2 only: Subjects must have recurrent disease after receiving a maximum of two prior chemotherapy regimens including at least one platinum containing regimen.
    • Eastern Cooperative Oncology Group (ECOG) performance status of <= 1. (ECOG performance status of 0 or 1).
    • Tumor tissue requirements: Availability of archival tissue, or willingness to undergo fresh biopsy at baseline; Enrollment in PK/PD cohort may be limited to subjects with disease amenable to pre- and post-dose biopsies, and willingness to undergo biopsy.
    • All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)
    • Adequate baseline organ function
    • Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol, during the study and for 7 days following the last dose of study treatment.
    • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in protocol from the administration of the first dose of study treatment until 3 months after the last dose of study treatment to allow for clearance of any altered sperm.
    • Able to swallow and retain orally administered study treatment and does not have any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
    • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

    Exclusion Criteria:

    • Concurrent malignancy other than SCLC. History of other malignancy is allowed as long as there is no evidence of active disease or need for treatment.
    • Currently receiving anti-cancer therapy. Exceptions: Zoledronic acid and denosumab to treat bone metastasis are allowed.
    • Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration. Chemotherapy regimens with delayed toxicity within the last four weeks (six weeks for prior nitrosourea or mitomycin C). Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity or palliative radiation to a limited area within the last two weeks.
    • Administration of an investigational drug within 28 days or 5 half-lives, whichever is shorter preceding the first dose of study treatment(s) in this study.
    • French subjects: The French subject has participated in any study using an investigational study treatment(s) during the previous 28 days.
    • Subjects with current/a history of bleeding disorder or coagulopathy or who are at particularly high risk for bleeding complications.
    • Requiring anticoagulants at therapeutic doses or platelet inhibitor.
    • Current use of a prohibited medication or expected to require any of these medications during treatment with the investigational drug
    • Evidence of severe or uncontrolled systemic diseases. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator
    • Known active Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infections. Subjects with laboratory evidence of HBV clearance may be enrolled
    • Leptomeningeal metastases or spinal cord compression due to disease.
    • Subjects with previously untreated or uncontrolled brain metastases.
    • Cardiac abnormalities
    • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2879552 or LSD1 inhibitors that contraindicates their participation.
    • Lactating female
    • Consumption of Seville oranges, grapefruit, grapefruit hybrids, grapefruit juice, pommelos, or exotic citrus fruits, from 1 day prior to the first dose of study treatment(s) until the last dose of study drug.
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  • open for enrollment

    A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    Protocol: OSU-13140

    Eligibility:

    Inclusion Criteria:

    • Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
    • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
    • Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for >= 6 months after the last dose
    • Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a complete response (CR) or partial response (PR)
    • Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs >=9 months from the first dose)
    • Evidence of measurable disease at screening as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
    • Able to receive intravenous (IV) dexamethasone or an equivalent IV corticosteroid
    • Have a known BRCA 1/2 mutation status (for participants who do not have a known BRCA 1/2 status at screening, a blood sample will be collected to determine the status with the results available prior to randomization
    • Laboratory values within protocol -defined parameters
    • Have left ventricular ejection fraction by multigated acquisition scan (MUGA) scan or 2D-ECHO within normal limits for the institution
    • Have side effects (except alopecia) of prior treatment resolved to at least Grade 1 according to the National Cancer Institute - Common Terminology Criteria of Adverse Events (NCICTCAE) (Version 4.0)
    • Have a negative urine or serum pregnancy test at screening
    • Agrees to protocol-defined use of effective contraception

    Exclusion Criteria:

    • Diagnosis of ovarian carcinoma with mucinous histology
    • Had more than 2 prior lines of chemotherapy
    • Prior exposure to trabectedin or hypersensitivity to any of the excipients
    • Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m2 (calculated using doxorubicin equivalent doses: 1 mg doxorubicin = 1 mg Doxil/Caelyx = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin)
    • Unwilling or unable to have a central venous catheter placed
    • Pregnant or breast-feeding
    • Less than 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy
    • History of another neoplastic disease (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for 5 years
    • Known allergies, hypersensitivity, or intolerance to Doxil, dexamethasone, or their excipients
    • Known history of central nervous system metastasis
    • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy)
    • Had a myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
    • Has any of the following medical conditions: uncontrolled diabetes, psychiatric disorder (including dementia) that prevents compliance with protocol, uncontrolled seizures, newly diagnosed deep vein thrombosis, active systemic infection that is likely to interfere with study procedure or results
    • Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

    Protocol: OSU-14251

    Eligibility:

    Inclusion Criteria:

    • Adults with AML in need of treatment (except individuals with acute promyelocytic leukemia M3)
    • Individuals = 18 and < 60 years of age with previously untreated AML by World Health Organization (WHO) criteria
    • Individuals between 60 to 70 years of age are eligible regardless of risk group
    • Individuals > 70 years of age with previously untreated AML
    • Individuals = 70 years of age who refuse or are unable to receive daunorubicin and cytarabine (3+7) chemotherapy as determined by the treating physician

    Exclusion Criteria:

    • Known active central nervous system or leptomeningeal lymphoma

    Principal Investigator: Alison R Walker, MD

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  • open for enrollment

    Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma

    Protocol: OSU-13128

    Eligibility:

    Inclusion Criteria:

    • Patients have evidence of relapse or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following:
    • Serum M-protein >= 0.5 g/dl (>= 10 g/l)
    • Urine monoclonal protein >= 200 mg/24h
    • Involved free light chain (FLC) level >= 10mg/dl (>= 100mg/l) and an abnormal serum free light chain ratio (< 0.26, or > 1.65)
    • Measurable biopsy proven plasmacytoma (should be measured within 28 days of initial investigational agent dosing)
    • Patients must have had at least 2 prior line of therapy
    • Patients must not have had progression of disease on lenalidomide 25 mg; stable disease on lenalidomide is permitted
    • Patient may be enrolled at any time from last line of therapy
    • Absolute neutrophil count (ANC) > 1000/uL
    • Platelets >= 75,000/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is > 30%, platelet eligibility requirement will be adjusted to 60,000/uL
    • Total bilirubin =< 1.5 mg/dL
    • Alkaline phosphatase =< 3 X the upper limit of normal (ULN)
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 X the ULN
    • Serum creatinine =< 2 mg/dL or calculated creatinine clearance of >= 40 ml/min within 14 days of registration using Modification of Diet in Renal Disease (MDRD) formula
    • Patient must be able to swallow capsule or tablet
    • Patients must provide informed consent
    • Patients must have a left ventricular ejection fraction > 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
    • Patients must have a Karnofsky performance status >= 70
    • A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
    • Fertility requirements:
    • Female patients with child bearing potential must have a negative pregnancy test at least 7 days before starting treatment drugs
    • Male patients must agree to use an adequate method of contraception for the duration of the study and for 90 days afterwards
    • Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and for 90 days afterwards
    • Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program

    Exclusion Criteria:

    • Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
    • Prior exposure to anti programmed cell death 1 (PD1) or anti programmed cell death 1 ligand 1 (PDL1)
    • Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
    • History of allergic reaction (including erythema nodosum) to lenalidomide
    • Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
    • Patients with contraindication to thromboprophylaxis
    • Unacceptable cardiac risk factors defined by any of the following criteria: patients with congenital long QT syndrome, any history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate (HR) < 50 bpm, left ventricular ejection fraction < 30%
    • Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies
    • Patients who have undergone major surgery =< 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
    • Patients with known positivity for human immunodeficiency virus (HIV), or hepatitis C; baseline testing for HIV and hepatitis C is not required
    • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix should not be enrolled; patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from a prior malignancy for >= 5 yrs and are considered by their physician to be less than 30% risk of relapse
    • Patients with active (untreated or relapsed) central nervous system (CNS) metastasis of the patient's myeloma
    • Patients with a history of gastrointestinal surgery or other procedure that might, in the opinion of the investigator(s), interfere with the absorption or swallowing of the study drugs
    • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff
    • Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

    Principal Investigator: Yvonne A Efebera, MD, Affiliate

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  • open for enrollment

    GSK2141795, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

    Protocol: SWOG-S1221

    Eligibility:

    Inclusion Criteria:

    • PHASE I PORTION ELIGIBILITY CRITERIA
    • Patients must have BRAF^V600 mutant metastatic cancer irrespective of the histology or prior therapy; BRAF^V600 mutant status must be documented by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; use of an Food and Drug Administration (FDA)-approved test is preferred although other BRAF tests at a CLIA-certified laboratory may also be accepted
    • Patients must have locally advanced unresectable stage IIIC or metastatic stage IV cancer with either progression to prior therapy or a newly diagnosed cancer that does not have an available treatment with curative intent
    • Patients must have a complete physical examination and medical history within 28 days prior to registration
    • Patients must have measurable or non-measurable disease; all measurable lesions must be assessed (by physical examination, computed tomography [CT], or magnetic resonance imaging [MRI] scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
    • All patients must undergo a CT or MRI of the brain within 42 days prior to registration; patients with asymptomatic brain metastases or previously treated brain metastases that are stable (i.e. not requiring corticosteroids) at the time of registration will be eligible
    • Patients may have received prior systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens); all adverse events associated with prior treatment must have resolved to =< grade 1 prior to registration
    • Patients progressing on a prior BRAF inhibitor-based therapy will be eligible, as are patients naïve to BRAF inhibitor therapy; resistance to BRAF inhibitor-based therapy will be defined as progressive disease by RECIST 1.1 criteria while receiving therapy with a BRAF inhibitor (vemurafenib or dabrafenib, alone or in combination with a mitogen-activated protein kinase [MEK] inhibitor); this may be innate resistance (patients who never achieved a tumor response while on BRAF inhibitor therapy) or acquired resistance (progression after having a tumor response to BRAF inhibitor therapy); there will not be a period of break between progression on the prior BRAF inhibitor-based therapy and the start of dabrafenib and GSK2141795
    • Patients may have received prior surgery (for both the primary and stage IV disease); all adverse events associated with prior surgery must have resolved to =< grade 1 prior to registration
    • Patients may have received prior radiation therapy; all adverse events associated with prior radiation therapy must have resolved to =< grade 1 prior to registration
    • Patients must be willing to submit blood for pharmacokinetics; sites must order S1221 pharmacokinetic (PK) kit immediately after registration; the Southwest Oncology Group (SWOG) patient identification (ID) number must be provided on the S1221 PK Kit request form
    • Patients must have available and be willing to submit baseline tissue taken at the time of disease progression to prior BRAF inhibitor-based therapy (either fresh frozen [preferred], or paraffin-embedded tumor blocks) OR must have a site of disease that can be biopsied within this study for translational medicine studies; tissue may be from an archival biopsy or a new biopsy after the patient has been registered to the protocol; since patients are referred to this protocol after progression on prior BRAF inhibitor-based therapy, the biopsy taken at the time of progression will be used as the baseline biopsy for this study; patients must be willing to submit plasma and whole blood for translational medicine studies
    • Patients must have Zubrod performance status =< 1
    • Absolute neutrophil count (ANC) >= 1,200/ul
    • Platelets >= 100,000/ul
    • Hemoglobin >= 9 g/dL
    • Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert's syndrome)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or < 5 x IULN for patients with known liver metastases)
    • Serum albumin >= 2.5 g/dL
    • Serum creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance >= 50 mL/min
    • Patient must have a left ventricular ejection fraction >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition (MUGA) within 28 days prior to registration
    • Patients must not have a corrected QT (QTc) interval >= 480 msecs within 28 days prior to registration
    • Patients must not have a history of acute coronary syndromes (including unstable angina), myocardial infarction within 6 months, coronary angioplasty, or stenting within the past 24 weeks; class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; or history of known cardiac arrhythmias (such as atrial fibrillation) unless it has been stably controlled for > 30 days prior to registration; abnormal cardiac valve morphology (>= Grade 2) documented by echocardiogram (subjects with Grade 1 abnormalities [i.e., mild regurgitation/stenosis]) can be entered on study; subjects with moderate valvular thickening are not eligible
    • Patients with melanoma must have a serum lactate dehydrogenase (LDH) test performed within 28 days prior to registration
    • Patients with human immunodeficiency virus (HIV) are eligible if they are not on antiviral agents and have adequate cluster of differentiation (CD)4 counts (>= 500 mm^3)
    • Patients receiving anticoagulation treatment are allowed to participate with international normalized ratio (INR) established within the therapeutic range
    • At the time of registration, patients must not be receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8); patients must not be planning to use herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1)
    • Women of childbearing potential must have a negative pregnancy test within 14 days of registration
    • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
    • Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, previously diagnosed type 1 diabetes mellitus/type 2 diabetes, psychiatric illness/social situations, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, that would limit compliance with study requirements; patients must not have any evidence of mucosal or internal bleeding; patients must not have received any major surgery within four weeks prior to registration
    • Patients must not have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
    • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib or other agents used in this study including dimethyl sulfoxide (DMSO)
    • Patients must be able to retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels; patients who have feeding tubes can enroll in the study provided that the capsules do not need to be modified
    • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
    • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
    • Patients must have a serum albumin >= 2.5 g/dL within 28 days prior to registration
    • Patients with known history or current evidence of retinal vein occlusion (RVO) are not eligible:
    • History of RVO, or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes)
    • Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO such as:
    • Evidence of new optic disc cupping
    • Evidence of new visual field defects
    • Intraocular pressure > 21 mmHg
    • NOTE: Ophthalmic exam is required for all patients; exam must be obtained within 28 days prior to registration
    • Patients must not have uncontrolled hypertension (defined as systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg which cannot be controlled by anti-hypertensive therapy)
    • PHASE II PORTION ELIGIBILITY CRITERIA
    • Patients must have histologically confirmed melanoma with BRAF^V600 mutation; patients must have stage IIIC or stage IV disease
    • Patients must have received prior BRAF inhibitor therapy (e.g. dabrafenib, vemurafenib) within 56 days prior to registration; prior trametinib therapy is permitted; patients are not required to interrupt BRAF or MEK inhibitor therapy prior to the initiation of three agent combination therapy on study
    • Patients must have measurable disease; all measurable lesions must be assessed (by physical examination, CT, or MRI scan) within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1)
    • Patients must have Zubrod performance status =< 2
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: Prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
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  • open for enrollment

    Cabozantinib-S-Malate in Treating Patients With Advanced Solid Tumors and Human Immunodeficiency Virus

    Protocol: AMC-087

    Eligibility:

    Inclusion Criteria:

    • Patients must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; any number of prior cancer therapies will be permitted; at least 4 weeks must have elapsed since prior chemotherapy or biological therapy, 6 weeks if the regimen included carmustine (BCNU) or mitomycin C; prior radiation therapy to the thoracic cavity, abdomen, or pelvis must be completed at least 3 months prior to registration; radiotherapy to any other site (including bone or brain metastases) must be completed at least 28 days prior to registration
    • Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immuno sorbent assay (ELISA), positive western blot, or any other federally approved licensed HIV test; alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and western blot, or other approved diagnostic tests
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
    • Life expectancy of greater than 12 weeks
    • Leukocytes >= 3,000/mcL
    • Absolute neutrophil count >= 1,500/mcL
    • Platelets >= 100,000/mcL
    • Total bilirubin=< 1.5 × upper limit of normal (ULN) (for subjects with Gilbert's disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia [without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation], =< 3 × ULN)
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 × institutional upper limit of normal
    • Creatinine =< 1.5 × ULN
    • Creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
    • Hemoglobin >= 9 g/dL
    • Serum albumin >= 2.8 g/dL
    • Lipase < 2.0 × ULN and no radiologic or clinical evidence of pancreatitis
    • Urine protein/creatinine ratio (UPCR) =< 1
    • Serum phosphorus >= lower limit of normal (LLN)
    • Calcium >= LLN
    • Magnesium >= LLN
    • Potassium >= LLN
    • A cluster of differentiation (CD)4+ lymphocyte count > 50/mcL will be required within 2 weeks of study participation
    • Women of childbearing potential must have a negative pregnancy test at screening; women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal; postmenopause is defined as amenorrhea >= 12 consecutive months; note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason
    • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of cabozantinib administration; sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 6 months after the last dose of study drug(s), even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 6 months after the last dose of study drug
    • Participating patients MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications, when clinically indicated and should be under the care of a physician experienced in HIV management; patients will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 8 weeks following study entry; as study-specific (antiretroviral-based) strata fill, however, only patients who are receiving the therapies eligible for the remaining open strata will be accrued
    • Ability to understand and the willingness to sign a written informed consent document
    • Subjects must in the opinion of the investigator be capable of complying with this protocol

    Exclusion Criteria:

    • Prior treatment with cabozantinib (XL184)
    • The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment
    • The subject has received prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 4 weeks or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment; note: Subjects with prostate cancer currently receiving luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH) agonists may be maintained on these agents
    • The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
    • The subject has not recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
    • The subject has a primary brain tumor
    • The subject has active brain metastases or epidural disease; subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 4 weeks before starting study treatment are eligible; subjects with treated brain metastasis should not take enzyme-inducing anticonvulsive therapies (EIACDs) within 2 weeks of registration, though non-enzyme inducing anticonvulsive drugs such as levetiracetam are allowed; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment; baseline brain imaging with contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) scans for subjects with known brain metastases is required to confirm eligibility
    • The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
    • The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
    • The subject requires chronic concomitant treatment with the following strong cytochrome P450 3A4 (CYP3A4) inducers OTHER than antiretroviral agents: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, primidone, modafinil, and other enzyme inducing anti-convulsant drugs (EIACD), and St. John's Wort; use of efavirenz or etravirine is permitted for patients considered for the CYP3A4-inducer based antiretroviral therapy (ART) regimen arm (Stratum B) of the trial
    • The subject requires concomitant treatment with the following inhibitors of CYP3A4:
    • Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin
    • Antifungals: itraconazole, ketoconazole, voriconazole, fluconazole, posaconazole
    • Antidepressants: nefazodone
    • Antidiuretic: conivaptan
    • Gastrointestinal (GI): cimetidine, aprepitant
    • Hepatitis C: boceprevir, telaprevir
    • Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids); use of any of anti-retrovirals (delavirdine) or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) is permitted; specifically, ritonavir and cobicistat is permitted for patients considered for the CYP3A4-inhibitor based ART regimen arm (Stratum A) of the trial
    • The subject has experienced any of the following:
    • Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
    • Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment
    • Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
    • The subject has radiographic evidence of cavitating pulmonary lesion(s)
    • The subject has tumor in contact with, invading or encasing any major blood vessels
    • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
    • Cardiovascular disorders including:
    • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
    • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
    • Any history of congenital long QT syndrome
    • Any of the following within 6 months before the first dose of study treatment:
    • Unstable angina pectoris
    • Clinically-significant cardiac arrhythmias
    • Stroke (including transient ischemic attack [TIA], or other ischemic event)
    • Myocardial infarction
    • Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
    • Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
    • Any of the following within 28 days before the first dose of study treatment
    • Active peptic ulcer disease
    • Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
    • Malabsorption syndrome
    • Any of the following within 6 months before the first dose of study treatment:
    • Abdominal fistula
    • Gastrointestinal perforation
    • Bowel obstruction or gastric outlet obstruction
    • Intra-abdominal abscess; Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 6 months before the first dose of study treatment
    • Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months before the first dose of study therapy
    • Other clinically significant disorders such as:
    • Active infection requiring systemic treatment within 28 days before the first dose of study treatment; patients with HIV infection will be eligible provided they meet the criteria; patients with known hepatitis B infection should be screened for active disease prior to study participation
    • Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
    • History of organ transplant
    • Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
    • History of major surgery as follows:
    • Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications
    • Minor surgery within 1 months of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications
    • In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
    • The subject is unable to swallow tablets that are whole (do not crush or chew or administer via nasogastric [NG]-tube)
    • The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 28 days before randomization; note: If initial QTcF is found to be > 500 ms, two additional electrocardiogram (ECGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib (XL184)
    • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with cabozantinib

    Principal Investigator: Christina Wu, MD

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  • open for enrollment

    Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

    Protocol: OSU-14084

    Eligibility:

    Inclusion Criteria:

    • ECOG Performance Status range of 0-2
    • Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
    • May be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma.
    • Must be able to undergo MRI and have at least one measurable intracranial lesion for which specific criteria have to be met.

    Exclusion Criteria:

    • Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular signal-regulated kinase inhibitor.
    • Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe.
    • Treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe.
    • Any presence of leptomeningeal disease or any parenchymal brain metastasis
    • History of another malignancy, some exceptions may apply.
    • A history or evidence of cardiovascular risk- specific criteria have to be met
    • A history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment - specific criteria have to be met.
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  • open for enrollment

    Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI

    Protocol: PRECOG-PRE0102

    Eligibility:

    Inclusion Criteria:

    1. Signed informed consent.

    2. =18 years.

    3. ECOG Performance Status 0 or 1.

    4. Histologically or cytologically confirmed adenocarcinoma of the breast.

    5. Stage IV disease or inoperable locally advanced disease.

    6. ER and/or PR-positive disease. Tumors must be HER-2/neu negative or equivocal.

    7. Aromatase Inhibitor (AI) resistant, defined as:

    • relapsed while receiving adjuvant therapy with an AI or,
    • progressive disease while receiving an AI for metastatic disease

    8. Received one prior dose of fulvestrant within 28 days of randomization are eligible.

    • =2 prior doses of fulvestrant are not eligible

    9. Must be female and postmenopausal.

    10. May have received =1 prior systemic chemotherapy regimen for metastatic disease.

    11. Adequate organ function:

    • WBC =3.0 x 10?/L, ANC =1.5 x 10?/L and platelet count =100 x 10?/L
    • hemoglobin =9 g/dL
    • serum bilirubin =1.5 X ULN (Upper Limit of Normal)
    • AST or ALT =2.5 X ULN (=5 x ULN in patients with liver metastases)
    • serum creatinine =1.5 X ULN
    • serum albumin =3 g/dL
    • fasting serum cholesterol =300 mg/dL OR =7.75 mmol/L AND fasting triglycerides =2.5 x ULN.
    • PT with INR =1.5

    12. May have measurable disease, non-measurable disease, or both.

    13. Basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix within the past five years treated with curative intent. History of prior malignancy are eligible if disease-free for >3 years.

    Exclusion Criteria:

    1. Major surgery or significant traumatic injury within 4 weeks of randomization or patients that may require major surgery during the course of the study.

    2. Investigational agents within 4 weeks of randomization.

    3. Anticancer treatment within 4 weeks of randomization, with the following exceptions:

    • Bisphosphonates or Zometa for bone metastases
    • a GnRH analog is permitted if the patient had progressive disease on a GnRH (Gonadotropin-Releasing Hormone) analog plus a SERM (Selective Estrogen Receptor Modulators) or an AI; the GnRH analog may continue but the SERM or AI must be discontinued.

    4. Prior treatment with an mTOR inhibitor.

    5. Receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent = 5 mg prednisone or equivalent daily.

    6. Receive immunization with attenuated live vaccines within one week of randomization or during the study period.

    7. Current or a prior history of brain metastases or leptomeningeal disease. Must not have rapidly progressive, life-threatening metastases.

    8. Known hypersensitivity/history of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or fulvestrant.

    9. Congenital or acquired immune deficiency at increased risk of infection.

    10. Impairment of gastrointestinal function/disease that may significantly alter the absorption of everolimus.

    11. Active, bleeding diathesis.

    12. History of any condition or uncontrolled intercurrent illness that in the opinion of the local investigator might interfere with or limit the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient.

    13. Severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

    • Symptomatic congestive heart failure of New York Heart Association Class III or IV
    • Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
    • History of symptomatic pulmonary disease or non-malignant pulmonary disease requiring treatment.
    • Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN
    • Active (acute or chronic) or uncontrolled severe infections
    • Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

    Note: Detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening.

    Principal Investigator: Bhuvaneswari Ramaswamy, MD

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  • open for enrollment

    Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer

    Protocol: GOG-0265

    Eligibility:

    Inclusion Criteria:

    • Patients must have persistent or recurrent squamous cell or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy)
    • Histologic confirmation of the original primary tumor is required via the pathology report
    • Patient must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded)
    • Each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray
    • Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
    • Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1
    • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
    • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists
    • In general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population
    • Patients must have a GOG performance status of 0 or 1
    • Recovered from effects of recent surgery, radiotherapy, or chemotherapy
    • Patients should be free of active infection requiring antibiotics
    • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
    • Continuation of hormone replacement therapy is permitted
    • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration
    • Any prior radiation therapy must be completed at least 4 weeks prior to registration
    • Patients must have had one prior systemic chemotherapeutic regimen for management of advanced, metastatic, or recurrent carcinoma of the cervix
    • Chemotherapy administered concurrent with primary radiation (e.g.; weekly cisplatin) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease; adjuvant chemotherapy given following the completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen for management of advanced, metastatic, or recurrent disease (e.g.; paclitaxel and carboplatin for up to 4 cycles)
    • Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for advanced, metastatic, or recurrent disease (e.g., bevacizumab)
    • Platelet count greater than or equal to 100,000/mcL
    • Absolute neutrophil count (ANC) count greater than or equal to 1,500/mcL
    • Lymphocyte count greater than or equal to 700/mcL
    • Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN)
    • Bilirubin less than or equal to 1.5 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 1.5 x ULN
    • Gamma-glutamyl transpeptidase (GGT) less than or equal to 1.5 x ULN
    • Alkaline phosphatase less than or equal to 2.5 x ULN
    • Neuropathy (sensory and motor) less than or equal to grade 1
    • Patients must have signed an approved informed consent and authorization permitting release of personal health information
    • Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy
    • Patients cannot be lactating
    • Patients must be able to swallow pills

    Exclusion Criteria:

    • Patients who have received prior therapy with ADXS11-001
    • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer or localized cancer of the breast, head and neck, or skin, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
    • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of cervical cancer within the last three years are excluded
    • Prior radiation for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than three years prior to registration and the patient remains free of recurrent or metastatic disease
    • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of cervical cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
    • Patients allergic to both penicillin and ciprofloxacin (including history of rash or anaphylaxis)
    • Patients allergic to naproxen
    • Patients currently receiving antibiotics
    • Patients who have received within the past four weeks, or who are currently receiving, corticosteroids
    • Topical corticosteroids and occasional inhaled corticosteroids are allowed
    • No patients with uncontrolled intercurrent illness including, but not limited to:
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
    • Patients with liver cirrhosis or any other impaired hepatic function as determined by serum enzymes
    • Patients known to be seropositive for human immunodeficiency virus (HIV) and/or active hepatitis, even if liver function studies are in the eligible range
    • Patients with a prior history of a splenectomy and/or sickle cell trait/disease

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

    Protocol: OSU-13184

    Eligibility:

    Inclusion Criteria:

    • Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist, or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least one of the following:

    1. The presence of at least one lesion, measuring = 2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.

    2. The presence of liver lesion(s) (as defined in a.) with AFP = 400 ng/mL.

    3. Tissue confirmation.

    • Biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent have been in place for at least 10 days prior to the first dose of crizotinib, and the liver function has stabilized as defined by 2 measurements at least 5 days apart that put the patient in the same hepatic dysfunction stratum as defined in Section 3.
    • Presence of gliomas and brain metastases only if neurologically stable and treated without ongoing requirement for corticosteroids for at least 2 weeks.
    • Any prior systemic therapy (e.g., chemotherapy, molecularly targeted agent, immunotherapy, etc.) or major surgery must have been completed at least 30 days (or as determined by the local requirement, whichever is longer), or at least 5 half lives for drugs with half lives of 6 days or longer prior to initiation of crizotinib treatment. Any prior radiation (except palliative) or minor surgeries/procedures must have been completed at least 2 weeks prior to the initiation of crizotinib treatment. Palliative radiation (= 10 fractions) must have been completed 48 hours prior to the initiation of crizotinib treatment. Any acute toxicity must have recovered to Grade =1 (except alopecia).
    • Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
    • Adequate organ function for patients receiving crizotinib therapy as defined by the following criteria:

    Bone marrow function

    • Absolute neutrophil count (ANC) = 750/uL
    • Platelets = 30,000/uL
    • Hemoglobin = 8.0 g/dL (= 7.0 g/dL for hematologic malignancy) Renal function
    • Creatinine = 1.5 x ULN or CrCl > 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional 1.5 x ULN
    • Male and female patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

    Exclusion Criteria:

    • Untreated esophageal varices observed on EGD or imaging study; however, patients with known portal hypertension and evidence of varices on EGD or imaging study who have undergone appropriate therapy as indicated within the last 6 months (if applicable) are eligible for enrollment.
    • Uncontrolled ascites that is not stable with medical management (i.e., on diuretics and salt restriction) as defined by requiring therapeutic paracentesis more than once every 4 weeks.
    • Episodes of hepatic encephalopathy within the last 4 weeks. Patients with prior episodes of hepatic encephalopathy who are clinically stable on lactulose, neomycin, and/or xifaxan therapy are allowed.
    • Prior therapy with crizotinib.
    • Spinal cord compression.
    • Carcinomatous meningitis or leptomeningeal disease
    • Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
    • Symptomatic congestive heart failure.
    • Ongoing cardiac dysrhythmias of NCI CTCAE Grade = 2, uncontrolled atrial fibrillation of any grade, or an average of triplicate QTc interval >470 msec.
    • History of extensive disseminated/bilateral or known presence of interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
    • Active hemolysis or evidence of biliary sepsis.
    • Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after last dose of investigational product; males and females of childbearing potential not using two (2) methods of highly effective contraception or not agreeing to continue two (2) methods of highly effective contraception for at least 28 days after last dose of investigational product.
    • Use of drugs or foods that are known strong CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice.
    • Use of drugs that are known strong CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
    • Use of drugs that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, and pimozide.
    • Other severe acute or chronic medical (may include severe gastrointestinal conditions such as chronic diarrhea or ulcer disease) or psychiatric conditions, or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of the study results and, in the judgment of the investigator, would make the patient inappropriate for study entry.
    • Patients who had prior major gastrointestinal surgery removing part of gastrointestinal tract and/or gall bladder.
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