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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

    Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers

    Protocol: OSU-14135

    Eligibility:

    Inclusion Criteria:

    • Subjects must be periodontally healthy; this is defined as all sites with attachment levels =< 2 mm and probing depths =< 3 mm) and caries-free, as evidenced by a DMF (decayed, missing, filled teeth) Index of less than 5
    • Body mass index (BMI) between 18.5 and 32 kg/m^2; this represents the lowest end of the healthy BMI range and one standard deviation above the mean BMI for our target age range
    • Subject must be either a current smoker or a never smoker; to define a smoker, we will utilize the Centers for Disease Control definitions; any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker; smoking status will be assessed by a questionnaire; since only current and never smokers are included, it is not necessary to measure cotinine levels; the number of cigarettes smoked per day and years of smoking will be used to calculate pack-years, which will be used as a measure of tobacco exposure; a never smoker is defined as a person who never smoked, or smoked less than 100 cigarettes in their lifetime, and who has not had a cigarette in over ten years
    • Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition, dietary or alternative medications/supplements for the duration of the study
    • Agree to follow a controlled ellagitannin/low polyphenolic diet and to document consumption of polyphenolic foods each day of the study using our easy to document daily form

    Exclusion Criteria:

    • Have history of oral cancer or carcinoma in-situ
    • Have had antibiotic therapy or professional cleaning within the previous 3 months
    • Require antibiotic therapy prior to oral cleaning
    • Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohn's disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > 1.4), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
    • Are alcohol consumers (defined as an average consumption of greater than 1 drink/day over one week [wk] [one drink = 1 oz. liquor, 12 oz. beer])
    • Are taking immunosuppressant medications, bisphosphonates or steroid medications
    • Currently undergoing treatment for cancer with chemotherapy, hormone therapy, radiation, or biological therapy
    • Have a known allergy or food intolerance to ingredients in study products (black raspberries or other berries)
    • Are planning to conceive, or are currently pregnant or lactating
    • Have had any active oral lesions in the past month or currently have any oral disease or obvious open sores in the oral cavity or surrounding the oral opening
    • Are taking any medications that have known impact on immune responses (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] for chronic pain) or are actively being investigated for the prevention of tobacco related cancers will not be acceptable; a single 81 mg aspirin per day will be acceptable

    Principal Investigator: Purnima Kumar, PhD, DDS

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  • open for enrollment

    A Study of IMC-CS4 in Subjects With Advanced Solid Tumors

    Protocol: OSU-10152

    Eligibility:

    Inclusion Criteria:

    • Subject has histologic or cytologic confirmation of advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
    • Subject has measurable or nonmeasurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
    • Subject has resolution to grade ≤1 by NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.03 of all clinically significant toxic effects of prior treatment
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Subject has adequate hematologic, hepatic, renal, and coagulation function
    • Subject has a life expectancy greater than 3 months
    • Subject agrees to use adequate contraception during the study period and for 12 weeks after last dose of study therapy

    Exclusion Criteria:

    • Subject has experienced acute pathologic fracture, spinal cord compression, or clinically significant hypercalcemia within 28 days prior to first dose of study therapy
    • Subject has a known hypersensitivity to monoclonal antibodies or other therapeutic agents, or to agents of similar biologic composition as IMC-CS4.
    • Subject has received treatment with any monoclonal antibodies within 6 weeks prior to first dose of study therapy
    • Subject has undergone a major surgical procedure, radiation therapy, open biopsy, or has experienced a significant injury within 28 days prior to enrollment
    • Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm
    • Subject has an ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, active bleeding or any other serious uncontrolled medical disorder
    • Subject has known or suspected primary brain or leptomeningeal metastases
    • Subject has leukemia or lymphoma
    • Subject is know to have active tuberculosis, leishmaniasis, or listeriosis
    • Subjects with known history, or clinical or laboratory evidence of liver disease
    • Subject has a known active hepatitis B or C infection, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
    • Subject if female, is pregnant or breastfeeding
    • Subject has received an organ transplant

    Principal Investigator: Robert Wesolowski, MD

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  • open for enrollment

    Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)

    Protocol: OSU-13257

    Eligibility:

    Inclusion Criteria for dose escalation and expansion phase:

    • Signed written informed consent
    • Male or female subjects aged greater than or equal to 18 years
    • Subjects must have histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for subjects in dose escalation
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months
    • Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST 1.1, except for subjects with metastatic castrate-resistant prostate cancer (mCRPC) or metastatic breast cancer (MBC) who may be enrolled with objective evidence of disease without a measureable lesion
    • Adequate hematological, hepatic and renal function as defined in the protocol
    • Effective contraception for both male and female subjects if the risk of conception exists
    • Other protocol defined inclusion criteria could apply

    Inclusion Criteria for expansion phase:

    • Subjects must have relapsed, refractory, or progressive disease following last line of treatment (with the exception of the gastric and gastroesophageal junction (GEJ) cancer cohort, which does not require progression). Availability of tumor archival material or fresh biopsies (excluding bone biopsies) is mandatory for eligibility in the expansion cohorts. For subjects in the MBC cohort, the biopsy or surgical specimen must have been collected within 90 days prior to the first investigational medicinal product (IMP) administration. Specifically, the following will be required:
    • NSCLC post platinum doublet: Histologically or cytologically confirmed stage IIIB or stage IV NSCLC that has progressed after 1 line of platinum-containing doublet chemotherapy. Subjects should have received only 1 line of platinum-containing treatment for metastatic disease (i.e., adjuvant treatment with a platinum-containing regimen is not sufficient for eligibility because not received in the context of a metastatic disease). Subjects in the NSCLC cohort will only be enrolled in USA
    • NSCLC first line: Stage IV (per 7th International Association for the Study of Lung Cancer [IASLC] classification) or recurrent NSCLC that is histologically proven. Subjects must not have received treatment for their metastatic or recurrent disease. No activating epidermal growth factor receptor (EGFR) mutation nor ALK translocation/re-arrangement
    • Gastric and GEJ cancer: Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction, treated with first-line chemotherapy combination with or without disease progression. Subjects should have received no more than 1 line of treatment for metastatic disease. Subjects should not have been treated with trastuzumab (but can be Human Epidermal growth factor Receptor 2 [HER2] positive). Subjects who received any platinum containing doublet or triplet as a neoadjuvant chemotherapy strategy, but are not ultimately candidates for surgery will also be eligible, as long as they did not have progressive disease after completion of the neoadjuvant chemotherapy. In addition, subjects with gastric cancer can enter in the study if their white blood cell (WBC) and lymphocyte count is as defined in the protocol
    • MBC: Subjects must have histologically confirmed locally advanced or MBC and have tumor that is refractory to or progressive after standard of care therapy. Subjects must have received no more than 3 prior lines of cytotoxic therapy for metastatic disease. Subjects must have received a taxane and an anthracycline, unless contra-indicated
    • Secondary expansion cohorts: Metastatic colorectal cancer (mCRC), Metastatic castrate-resistant prostate cancer (mCRPC), melanoma, ovarian cancer, ACC, mesothelioma, urothelial carcinoma and renal cell carcinoma as defined in the protocol
    • Efficacy expansion cohorts: Gastric and GEJ cancer (third line), ovarian cancer (platinum Refractory + liposomal doxorubicin), urothelial carcinoma, and HNSCC as defined in the protocol
    • Other protocol defined inclusion criteria for expansion phase could apply

    Exclusion Criteria for dose escalation and expansion phase:

    • Concurrent treatment with a non-permitted drug
    • Prior therapy with specific antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
    • Concurrent anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of trial treatment; or concurrent systemic therapy with immunosuppressive agents, use of hormonal agents within 7 days before the start of trial treatment as defined in the protocol. Note: Subjects receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab.
    • Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
    • Rapidly progressive disease (for example, tumor lysis syndrome)
    • Active or history of central nervous system metastases
    • Receipt of any organ transplantation including allogeneic stem-cell transplantation
    • Significant acute or chronic infections as defined in the protocol
    • Active or history of any autoimmune disease (subjects with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies
    • Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
    • Persisting toxicity related to prior therapy greater than Grade 1 NCI-CTCAE v4.0, however sensory neuropathy less than or equal to Grade 2 is acceptable
    • Pregnancy or lactation period
    • Known alcohol or drug abuse
    • Clinically significant (that is, active) cardiovascular disease
    • All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment
    • Any psychiatric condition that would prohibit the understanding or rendering of informed consent
    • Legal incapacity or limited legal capacity
    • Non-oncology vaccine therapies for prevention of infection disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine

    Principal Investigator: John L Hays, MD, PhD

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  • open for enrollment

    A Blanket Protocol to Study Oral Regorafenib in Patients With Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing-like Sarcomas

    Protocol: OSU-14056

    Eligibility:

    Inclusion Criteria:

    • Patients must have histologically or cytologically confirmed advanced/metastatic liposarcoma, osteogenic sarcoma, or Ewing/Ewing-like sarcoma of soft tissue or bone. This study will accept the diagnosis made at the investigator's center.
    • WHO Performance Status 0, 1 or 2. A maximum of 1/3 of patients in cohorts A & B may be WHO performance status 2.
    • At least one prior line of systemic therapy for the sarcoma diagnosis (neoadjuvant, adjuvant or metastatic disease).
    • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v 4.0 Grade 1 or less (except alopecia) at the time of signing the Informed Consent Form (ICF).
    • Subject must be able to swallow and retain oral medication.
    • At least one site of measurable disease on x-ray/CT/MRI scan as defined by RECIST 1.1. Baseline imaging must be performed within 28 days of Day 1 of study.
    • Adequate organ function within 14 days of registration INR (International Normalized Ratio) : patients with no prior evidence of underlying abnormality in coagulation parameters exists, according to the written documentation of the treating physician
    • Evidence of progression of disease as defined by RECIST 1.1 (i.e. new disease sites or 30% growth of index lesions) within 6 months of registration
    • Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS (central nervous system) metastatic disease and are without evidence of clinical progression for at least 12 weeks after therapy.

    Exclusion Criteria:

    • Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease.
    • Prior systemic therapy with a small molecule oral kinase inhibitor, including but not limited to: pazopanib, sunitinib, sorafenib, everolimus, sirolimus, vemurafenib, dasatinib.
    • Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study. Patients who progress on placebo are specifically allowed to enroll on the treatment arm of the study if they meet all other entry criteria.
    • Concurrent, clinically significant, active malignancies within 12 months of study enrollment
    • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
    • Major surgery within 28 days prior to study registration or those patients who have not recovered adequately from prior surgery
    • Patients who have received wide field radiotherapy ≤ 28 days (defined as > 50% of volume of pelvis bones or equivalent) or limited field radiation for palliation < 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy.
    • Patients who have received prior systemic therapy < 14 days prior to study registration or have not recovered adequately from toxicities to CTCAE v. 4.0 grade 1 or less; prior investigational therapy may not have been given < 5 half-lives of last dose of treatment, or < 14 days, whichever is greater.
    • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v 4.0] on repeated measurement) despite optimal medical management.
    • Active or clinically significant cardiac disease including: Congestive heart failure-New York Heart Association (NYHA) > class II, Active coronary artery disease, Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, Unstable angina (anginal symptoms at rest), new onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization3.2.11
    • Evidence or history of bleeding diathesis or coagulopathy
    • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration
    • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment
    • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
    • Ongoing infection > Grade 2 NCI-CTCAE v 4.0
    • Presence of a non-healing wound, non-healing ulcer, or benign bone fracture (patients with stress insufficiency fractures e.g. from osteoporosis or pathological fracture from tumor are eligible for study)
    • Patients with seizure disorder requiring medication
    • Persistent proteinuria: Grade 3 NCI-CTCAE v 4.0 (> 3.5 g/24 h, measured by urine protein:creatinine ratio on a random urine sample)
    • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
    • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea)
    • History of organ allograft (including corneal transplant).
    • Known or suspected allergy or hypersensitivity to regorafenib, or excipients of the formulations given during the course of this trial.
    • Any malabsorption condition.
    • Women who are pregnant or breast-feeding.
    • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
    • Inability to comply with protocol required procedures.
    • Use of any herbal remedy (e.g. St. John wort [Hypericum perforatum]).
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  • open for enrollment

    Ponatinib Hydrochloride in Treating Patients With Refractory Metastatic Cancers and Genetic Alterations

    Protocol: OSU-14078

    Eligibility:

    Inclusion Criteria:

    • Patients with histologically or cytologically confirmed diagnosis of refractory metastatic solid tumor or chronic hematological malignancy who are eligible for investigational drug therapy
    • Patients must have tumor suitable for biopsy (as assessed by trained specialists in interventional radiology) and medically fit to undergo a biopsy or surgical procedure OR if patients do not have a tumor suitable for biopsy but have another tissue available for molecular evaluation
    • Patients should have activating genomic alterations in FGFR (mutations, fusions or amplifications [> 6 copies]) or activating genomic alterations in KIT, platelet-derived growth factor receptor alpha [PDGFRα], ret proto-oncogene [RET], ABL proto-oncogene 1, non-receptor tyrosine kinase [ABL1] and fms-related tyrosine kinase 3 [FLT3] by any validated Clinical Laboratory Improvement Amendments [CLIA]-certified molecular testing (fluorescent in situ hybridization [FISH], polymerase chain reaction [PCR] or sequencing data are acceptable); CLIA validated results from other institutions; diagnostic labs (e.g. foundation medicine) are acceptable; additional types of activating alterations in these genes can be approved by the principal investigator (PI)
    • Patients with advanced cancers should have had at least one prior therapy that is considered standard for that disease type
    • Patients with solid tumors must have measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
    • Life expectancy of greater than 3 months
    • Patients with multiple malignancies remain eligible
    • Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
    • Patients must have controlled blood pressure with a systolic blood pressure < 140 mmHg and diastolic < 90 mmHg; anti-hypertensive medications are permitted
    • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and through 4 months after the end of treatment; for females of childbearing potential, a negative pregnancy test must be documented prior to randomization
    • Absolute neutrophil count >= 1,500/mcL
    • Platelets >= 75,000/mcL
    • Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome (< 5 if liver involvement with primary tumor)
    • Serum lipase and amylase =< 1.5 x ULN
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
    • Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by echocardiogram (ECHO) or multi gated acquisition (MUGA)
    • Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
    • Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:

    • Patients with acute hematological malignancies (e.g. acute myeloid leukemia)
    • Major surgery (e.g. thoracic, abdominal, vascular, neurosurgery) within 28 days prior to initiating therapy
    • History of acute pancreatitis within one year of study or history of chronic pancreatitis
    • History of alcohol abuse
    • Have uncontrolled hypertriglyceridemia (triglycerides > 450 mg/dL)
    • Patients who are receiving any other investigational therapeutic agents
    • Patients with gastrointestinal stromal tumor (GIST)
    • Patients with history of clinically significant bleeding disorder
    • Patients with chronic myelocytic or myelogenous leukemia (CML)
    • Patients with multiple myeloma and t(4; 14) translocation with aberrant expression of wild type FGFR3 by immunoglobulin (IgH) promoter (conversely, patients with t (4; 14) translocation and FGFR3 mutation remain eligible)
    • Pregnant women are excluded from this study; breastfeeding should be discontinued
    • Patients who are incarcerated are not eligible
    • Patients with any history of arterial thromboembolic disease; any patient with a history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina or peripheral vascular disease will not be eligible
    • Patients with history of recurrent venous thromboembolism (deep venous thrombosis or pulmonary embolism) or history of venous thromboembolism within 6 months will not be eligible
    • Patients with history of active hepatitis B or C infection or chronic hepatitis with Child Pugh B or C hepatic dysfunction
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ponatinib
    • Patients with history of atrial arrhythmia (requiring any anti-arrhythmic therapy) or patients with any history of ventricular arrhythmia are excluded
    • Clinically significant, uncontrolled intercurrent illness including, but not limited to:
    • Symptomatic or active infection
    • Uncontrolled hypertension (diastolic blood pressure > 90 mm Hg; systolic > 140 mm Hg); patients with hypertension should be under treatment on study entry to effect blood pressure control
    • Psychiatric illness/social situations that would limit compliance with study requirements
    • Patients with history of congestive heart failure or LVEF less than lower limit of normal per local institutional standards are excluded
    • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
    • Patients on medications known to be associated with Torsades de Pointes
    • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
    • Patients taking medications or herbal supplements that are known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors within at least 14 days before the first dose of ponatinib are excluded
    • Patients with symptomatic or progressive brain metastases are ineligible; subjects with treated brain metastases are eligible if they have no radiographic or other signs of progression in the brain for >= 4 weeks after completion of local therapy
    • Patients who have received prior FGFR targeted therapy

    Principal Investigator: Sameek Roychowdhury, MD, PhD

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  • open for enrollment

    INHERIT EGFR - Studying Germline EGFR Mutations

    Protocol: OSU-14072

    Eligibility:

    Inclusion Criteria:

    • Diagnosis of cancer of any type with an EGFR T790M mutation identified on genotyping of cancer; or
    • Have a first- or second-degree relative known to carry a germline EGFR mutation; or
    • Have a known germline EGFR mutation

    Exclusion Criteria:

    • Subjects with lung cancer and an acquired T790M mutation first detected after exposure to an EGFR tyrosine kinase inhibitor such as erlotinib or gefitinib
    • Too ill to complete the study questionnaire or provide the necessary specimen for testing
    • Unable to give informed consent
    • Unable to speak or read English
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  • open for enrollment

    Methods Project 4: Clinical Trial

    Protocol: OSU-14104

    Eligibility:

    Inclusion Criteria: - Male or female subjects who are at least 18 years of age; - Daily smoker; - Generally good health; - Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products); Exclusion Criteria: - Unstable health - Pregnant or breastfeeding (due to toxic effects from tobacco products). - Unable to read for comprehension or completion of study documents.

    Principal Investigator: Peter Shields, MD

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  • open for enrollment

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

    Protocol: OSU-13211

    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

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  • open for enrollment

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

    Protocol: OSU-11024

    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
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