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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

    Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

    Eligibility:

    DISEASE CHARACTERISTICS:

    • Histologically or cytologically documented small cell lung cancer (SCLC)
    • Limited-stage disease
    • Disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes
    • The following patients are not eligible:
    • Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes
    • Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not
    • Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray
    • Measurable disease, defined as at least one unidimensionally measurable lesion = 2 cm by conventional techniques OR = 1 cm by spiral CT scan

    PATIENT CHARACTERISTICS:

    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Granulocytes = 1,500/µl
    • Platelet count = 100,000/µl
    • Total bilirubin = 1.5 times upper limit of normal (ULN)
    • AST = 2.0 times ULN
    • Serum creatinine = 1.5 times ULN OR creatinine clearance = 70 mL/min
    • Not pregnant or nursing
    • Negative pregnancy test
    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    • Patients may have received one and only one course of chemotherapy prior to enrolling on CALGB 30610, which must have included cisplatin and etoposide
    • If a patient has had one course of cisplatin/etoposide prior to registration, the patient must have had all of the prior-to-registration tests prior to starting their first course of chemotherapy
    • Registration to CALGB-30610 must take place within 14-21 days after the start of the non-protocol therapy; failing to do all of the above will make the patient NOT eligible for CALGB-30610
    • No prior radiotherapy or chemotherapy (except for the chemotherapy described above) for SCLC
    • No prior mediastinal or thoracic radiotherapy
    • No prior complete surgical resection of SCLC
    Learn More
  • open for enrollment

    Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

    Eligibility:

    Inclusion Criteria:

    • Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
    • Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
    • Written informed consent and/or Consent waiver by institutional review board (IRB)

    Exclusion Criteria:

    • Unexplained fever and/or untreated, active infection
    • Patient pregnancy
    • Previous head and neck surgery precluding transoral/robotic procedures
    • The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
    • Inability to grant informed consent
    • INTRAOPERATIVE EXCLUSION CRITERIA:
    • Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
    Learn More
  • open for enrollment

    CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

    Eligibility:

    Inclusion Criteria:

    • Have a working phone number
    • Resident of one of the 12 study counties
    • Lived in that study county since the start of the project
    • No prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease)
    • Not currently pregnant
    • Be in good health (i.e., no contraindications to CRC screening)

    Exclusion Criteria:

    • No working phone number
    • Not a resident of one of the 12 study counties
    • Does not live in the study county since the start of the project
    • Has a prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease)
    • Is currently pregnant
    • Not in good health(i.e.has contraindications for CRC screening)

    Principal Investigator: Electra D Paskett, PhD

    Learn More
  • open for enrollment

    Study of BKM120 & Rituximab in Patients With Relapsed or Refractory Indolent B-Cell Lymphoma

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically confirmed indolent B-cell NHL or mantle cell lymphoma; acceptable subtypes of indolent B-cell NHL include follicular lymphoma (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia; patients with mantle cell lymphoma must have a documented t(11;14) or overexpression of cyclin D1 by immunohistochemical evaluation; patients with active large cell transformation are not eligible; however, patients with a history of large cell transformation are eligible provided that there is no current clinical evidence of active transformed lymphoma
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • At least one prior therapy; prior autologous or allogeneic stem cell transplant is allowed; patients may not be on chronic immunosuppressive therapy for graft-versus-host disease (GVHD); patients who have received prior treatment with a pan-selective PI3K inhibitor are not eligible; however, prior therapy with a selective PI3K inhibitor, Bruton's tyrosine kinase inhibitor, or other B-cell receptor targeting agents is allowed
    • Serum creatinine =< 2.0 mg/dL
    • Total bilirubin =< upper limit of normal
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limit of normal
    • Absolute neutrophil count (ANC) >= 750/mm^3
    • Platelets >= 50,000/ mm^3
    • Serum lipase =< upper limit of normal
    • Serum amylase =< upper limit of normal
    • International normalized ratio (INR) =< 2.0
    • Fasting glucose < 120mg/dL
    • Recovery to =< grade 1 toxicities associated with prior therapy
    • Negative serum pregnancy test; if, on cycle 1 day 1, greater than 72 hours has elapsed since the last negative result, a serum pregnancy test must be repeated and be negative on cycle 1 day 1 (C1D1) for the patient to remain eligible
    • Patient has the ability and willingness to provide informed consent and has signed the informed consent document

    Exclusion Criteria:

    • Pregnant or breast-feeding women and women of childbearing age or men who are unwilling to use adequate contraception; females of childbearing age and potential (i.e., not surgically sterilized) must use a second form of contraception, including total abstinence, intra-uterine device, double-barrier contraception, or other non-hormonal form of contraception
    • Patients with a history of central nervous system involvement by lymphoma
    • The presence of co-existing medical conditions that would limit compliance with study medications, including, but not limited to active infection, active or untreated cardiac or pulmonary disease, or malignancy
    • Patients with significant, symptomatic deterioration of lung function confirmed by spirometry, diffusion capacity of carbon monoxide (DLCO), or resting oxygen (O2) saturation
    • Patients with impairment of gastrointestinal function that may alter the absorption of BKM120
    • Patients currently being actively treated or who have been treated within the past 3 years for an unrelated malignancy (except non-melanoma skin cancer, cervical carcinoma in-situ, and low risk prostate cancer)
    • Patients who have undergone major surgery within 2 weeks prior to study enrollment or who have not recovered from a major surgery
    • Patients with known human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active or carriers)
    • Patients with a fasting blood glucose >= 120 mg/dL (6.7mmol/L); patients with diabetes mellitus are eligible if they require oral agents only and have a fasting blood glucose =< 120 mg/dL; patients with a history of diabetes mellitus who require daily long-acting or mealtime insulin are not eligible; patients who have previously required treatment for hyperglycemia due to steroids or other medications are eligible as long as they have not required insulin or any other oral agent within 2 months prior to study enrollment
    • Patients who are on chronic steroids for unrelated conditions (i.e. rheumatologic conditions) are not eligible if their total daily dose of steroids is >= 10mg prednisone
    • Patients with a known hypersensitivity to BKM120 or its excipients
    • Patients with active moderate or severe major mood or psychiatric disorder as judged by the investigator, primary care physician, counselor, psychiatrist, or as a result of the patient's mood assessment questionnaire that may interfere with the ability to comply with the trial; in addition, given the prior mood-associated toxicities, patients with a history of psychiatric hospitalization within the past 5 years, electroconvulsive therapy (ECT) within the past 5 years, or whose psychiatric condition has been unstable within 2 months prior to study enrollment requiring addition or change of psychotropic medications are not eligible; examples include, but are not limited to:
    • Medically documented history of or active major depressive episode requiring inpatient or intensive outpatient therapy, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or active ideation, or homicidal ideation (immediate risk of doing harm to others); patients under the care of a primary care physician who are treated with one oral agent and who have not required dose adjustments or new medications within 2 months prior to study enrollment and who otherwise meet eligibility requirements may be enrolled
    • >= Common Terminology for Adverse Events (CTCAE) version 4.0 grade 3 anxiety
    • Patients meeting the cutoff score of >= 12 in the Patient Health Questionnaire-9 (PHQ-9) or a cut-off of >= 15 in the Generalized Anxiety Disorder-7 (GAD-7) mood scale, respectively, or who select a positive response of "1, 2, or 3" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) are not eligible
    • Patients with diarrhea >= CTCAE grade 2
    • Patients with active cardiac disease including any of the following:
    • Left ventricular ejection fraction < 50% as determined by multi gated acquisition scan (MUGA) scan or echocardiogram
    • Corrected QT interval (QTc) > 480 msec on screening ECG (using the QTcF formula)
    • Active angina pectoris
    • Ventricular arrhythmias except for benign premature ventricular contractions
    • Supraventricular or nodal arrhythmias or any conduction abnormality requiring a pacemaker or automatic implantable cardioverter defibrillator (AICD)
    • Valvular disease with documented compromise in cardiac function
    • Symptomatic pericarditis
    • Myocardial infarction within the past 6 months
    • Congestive heart failure (New York Heart Association [NYHA] functional classification III-IV)
    • Patients who are currently receiving treatment with medications with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to study enrollment
    • Patients who have taken herbal medications and certain fruits within 7 days prior to study enrollment are not eligible; herbal medications include, but are not limited to, St John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng; exclusionary fruits include the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A) inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits
    • Patients who are currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to study enrollment; (please note that co-treatment with weak inhibitors of CYP3A is allowed)
    • Patients who have received oral or IV chemotherapy, targeted anticancer therapy or radiation therapy =< 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to study enrollment
    • Patients who are currently taking therapeutic doses of warfarin sodium or any other Coumadin-derivative anticoagulant; patients who can be safely changed to enoxaparin or other non-warfarin derived anti-coagulant and who otherwise meet eligibility requirements may be enrolled
    Learn More
  • open for enrollment

    IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

    Eligibility:

    Inclusion Criteria:

    • Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL).
    • Adequate organ function
    • ECOG = 2
    • Recovered or stabilized from prior treatments.

    Exclusion Criteria:

    • Allogeneic stem cell transplantation
    • Pregnant or lactating females
    • Known central nervous system, meningeal or epidural disease including brain metastases
    Learn More
  • open for enrollment

    Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery

    Eligibility:

    Inclusion Criteria:

    • Written informed consent in accordance with federal, local, and institutional guidelines
    • Patients with unresectable melanoma
    • Patients must have received at least one prior systemic anticancer regimen (chemotherapy, biologic therapy, or targeted therapy) for metastatic disease
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Total white blood cell (WBC) count >= 3000/mm^3
    • Absolute neutrophil count (ANC) >= 1500/mm^3
    • Platelet count >= 100,000/mm^3
    • Bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 times ULN)
    • Alanine aminotransferase (ALT) < 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT < 5.0 times ULN is acceptable
    • Estimated creatinine clearance of >= 50 mL/min, calculated using the formula of Cockroft and Gault
    • Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose

    Exclusion Criteria:

    • Patients who are pregnant or lactating
    • Radiation, chemotherapy, immunotherapy or any other systemic anticancer therapy =< 3 weeks prior to initiation of therapy
    • Major surgery within four weeks before initiation of therapy
    • Unstable cardiovascular function:
    • Symptomatic ischemia, or
    • Uncontrolled clinically significant conduction abnormalities (e.g.: ventricular tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB] will not be excluded)
    • Congestive heart failure (CHF) of New York Heart Association (NYHA) class >= 3, or
    • Myocardial infarction (MI) within 3 months of initiation of therapy
    • Uncontrolled active infection within one week prior to first dose
    • Known to be human immunodeficiency virus (HIV) seropositive
    • Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus [HBV] surface antigen)
    • Patients with active central nervous system (CNS) malignancy
    • Asymptomatic small lesions are not considered active
    • Treated lesions may be considered inactive if they are stable for at least 3 months
    • Patients will be excluded if they have had a major resection of the bowel that could influence absorption, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation within 28 days prior to beginning study treatment
    • Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
    • History of seizures, movement disorders or cerebrovascular accident within the past 5 years
    • Patients with known macular degeneration or uncontrolled glaucoma
    • In the opinion of the investigator, patients who are significantly below their ideal body weight
    • Serious psychiatric or medical conditions that could interfere with treatment
    • Participation in an investigational anti-cancer study within 3 weeks prior to initiation of therapy
    • Concurrent therapy with approved or investigational anticancer therapeutic
    Learn More
  • open for enrollment

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

    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.
    Learn More
  • open for enrollment

    An Open-Label, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetics of VX-970 in Combination With Cytotoxic Chemotherapy

    Eligibility:

    Inclusion Criteria:

    Disease status

    • Parts A and B: Histologically confirmed advanced solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom regimens containing gemcitabine, cisplatin, and/or etoposide might be considered, and with measurable disease according to RECIST criteria
    • Part C1:
    • Advanced (Stage IIIB or IV, not eligible for resection or definitive radiotherapy), histologically confirmed squamous non-small cell lung cancer (NSCLC) and who have not previously received chemotherapy for metastatic disease.
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
    • Measurable disease according to RECIST criteria
    • Part C2:
    • Advanced (locally-advanced incurable or metastatic) histologically confirmed estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) negative breast cancer.
    • Received a prior taxane-based regimen and no more than 1 additional regimen in the metastatic setting
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample d. Measurable disease according to RECIST criteria
    • Part C3:
    • Histologically confirmed SCLC that has relapsed from, or was refractory to, prior chemotherapy. Refractory disease is defined as relapse within 90 days of completing chemotherapy, or lack of tumor response while on therapy.
    • Either has lesion amenable to biopsy before Day 1 or available archived tumor sample
    • Measurable disease according to RECIST criteria
    • Hematological and biochemical indices within protocol specified ranges at screening.

    Exclusion Criteria:

    • Radiotherapy (except for palliative reasons) endocrine therapy, immunotherapy, or chemotherapy during the previous 4 weeks
    • Parts A and B:
    • Greater than 6 cycles of prior treatment with cisplatin and/or carboplatin.

    (a) History of prior dose reductions or dose interruptions while receiving cisplatin or carboplatin due to toxicity from the platinum or intolerance to either agent.

    • More than 2 prior distinct chemotherapy regimens used for treatment of advanced stage disease containing DNA damaging agents:
    • Subjects with a history of Grade 3 or 4 thrombocytopenia or Grade 4 neutropenia while receiving prior therapy with cisplatin, carboplatin, or any of the DNA damaging agents listed above.
    • Part C1:
    • prior platinum therapy for squamous NSCLC
    • Received prior treatment for metastatic NSCLC
    • Part C2:
    • More than 2 prior chemotherapy regimens for the treatment of metastatic breast cancer
    • Any prior platinum therapy for breast cancer in any setting
    • Part C3:
    • In relapsed SCLC, more than 2 prior chemotherapy regimens or, in refractory SCLC, more than 1 prior chemotherapy regimen
    • Has not received at least 1 cycle of platinum based chemotherapy for SCLC
    • Unresolved toxicity of Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater from previous anti-cancer therapy or radiotherapy
    • History of brain or leptomeningeal metastases
    • Female subjects who are already pregnant or lactating, or plan to become pregnant within 6 months of the last dose of study drug are excluded. Female subjects of childbearing potential must adhere to contraception guidelines
    • Male subjects with partners of child-bearing potential must agree to adhere to contraception guidelines. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded
    • Major surgery =2 weeks before starting study drug, or incomplete recovery from a prior major surgical procedure
    • Serious cardiac or other co-morbid disease, as specified in the protocol
    • Prior bone marrow transplant or extensive radiotherapy to greater than 15% of bone marrow
    • Part C:
    • Current malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin

    Principal Investigator: Robert Wesolowski, MD

    Learn More
  • open for enrollment

    A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors

    Eligibility:

    Inclusion Criteria:

    • Has provided signed written informed consent for this study
    • Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
    • Is currently participating in a GSK-sponsored study of GSK2118436
    • Currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with GSK2118436 (either as monotherapy or as part of a combination treatment regimen)
    • For Cohort C only: Subjects must have a calcium phosphate product (CPP) of <4.4 mmol^2/L^2 (55 mg^2/dL^2) if they are to continue treatment with GSK1120212
    • Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
    • Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
    • Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment
    • 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:

    • Permanent discontinuation of GSK2118436 in the parent study due to toxicity or disease progression
    • Local access to commercially available GSK2118436
    • Currently receiving treatment with any prohibited medication(s)
    • Any unresolved toxicity > Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
    • Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
    • Presence of rheumatoid arthritis
    • Corrected QT (QTc) interval >/= 480 msec at the time of transition to this study
    • Left ventricular ejection fraction (LVEF) </= institutional lower limit of normal (LLN) by ECHO at the time of transition to this study
    • Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system at the time of transition to this study
    • Pregnant or lactating female
    • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor
    Learn More
  • open for enrollment

    Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

    Eligibility:

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Men and women = 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status = 1
    • Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
    • Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
    • Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

    Exclusion Criteria:

    • Active brain metastases or leptomeningeal metastases are not allowed
    • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or nonsquamous histologies
    • Subjects with active, known or suspected autoimmune disease

    Principal Investigator: Maura L Gillison, MD, PhD

    Learn More