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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

    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:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically 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:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    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.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    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 (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    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.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Exclusion Criteria:

    Inclusion Criteria:

    Disease status

    Parts A and B: Histologically or cytologically 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:

    For Pre-screening:

    Advanced (metastatic or locally-advanced unresectable and not eligible for definitive

    treatment, e.g., surgery/radiotherapy), histologically confirmed non-small cell lung

    cancer (NSCLC)

    Available historical tumor specimen at the time of pre-screening or willing to

    provide a tumor biopsy (core) if the biopsy may be considered as part of standard

    clinical practice for the patient

    Received or did not tolerate standard approved targeted therapy, if appropriate for

    tumor genotype

    For Screening:

    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.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    -Part C3:

    Advanced (locally-advanced incurable or metastatic) histologically confirmed SCLC

    that is platinum-resistant, defined as disease progression during initial treatment

    with a platinum-based regimen or progression within 90 days of completion of platinum

    therapy. Subjects with platinum-resistant disease may receive a second-line

    non-platinum-based chemotherapy and subsequently be enrolled to this study. Subjects

    who received and are resistant to a second-line platinum-based chemotherapy may also

    be enrolled into the study.

    Adequate available historical tumor specimen or willing to provide a tumor biopsy

    (core) if the biopsy may be considered as part of standard clinical practice for the

    patient

    Measurable disease according to RECIST criteria

    WHO performance status of 0 or 1

    Life expectancy of ≥12 week

    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 (6 weeks for nitrosoureas and Mitomycin-C,

    and 4 weeks for investigational medicinal products) or less than 4 drug half-lives,

    whichever greater, before first dose of study drug.

    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.

    Subjects with a known history of Grade 4 thrombocytopenia or Grade 4 neutropenia

    while receiving prior therapy.

    Part C1:

    Any cytotoxic chemotherapy beyond 1 line of platinum-based chemotherapy. One

    additional line of non-platinum based therapy in the advanced setting

    1. Pre-screening Only*: Subjects may currently be receiving platinum-based

    chemotherapy in the advanced setting, or have completed 1 line of

    platinum-based chemotherapy and are currently receiving a second-line

    non-platinum-based therapy or maintenance therapy

    2. There is no restriction on prior immunotherapy or targeted therapy unless

    combined together with a cytotoxic agent

    Any prior gemcitabine for the treatment of NSCLC in any setting within 6 months

    Subjects who are known to be TP53 wild-type, unless they are determined to have

    ATM loss of expression during screening or pre-screening or until all the

    planned subjects with TP53 mutation are enrolled as determined by the medical

    monitor

    Subjects with unknown TP53 mutational status will be enrolled until the group of

    approximately 10 subjects

    Principal Investigator: Robert Wesolowski, MD

    Learn More
  • open for enrollment

    Ph III Randomized Mk-3475In Muscle Invasive And Locally Advanced Urothelial Carcinoma Versus Observa

    Protocol: ALLIANCE-A031501

    Principal Investigator: Amir Mortazavi, MD

    Learn More
  • open for enrollment

    Daratumumab and Ibrutinib for Symptomatic, Treatment-Naïve CLL: A Phase 1b Proof-of-Concept Study

    Protocol: OSU-17143

    Principal Investigator: Jennifer A Woyach, MD

    Learn More
  • open for enrollment

    ph I/II trial of Venetoclax & BEAM conditioning followed by auto-SCT for pts w/ primary refrac NHL

    Protocol: OSU-17225

    Principal Investigator: Basem M William, MD

    Learn More
  • open for enrollment

    Ph III Tabelecleucel for Subjects w/ Epstein-Barr Virus- (ALLELE Study)

    Protocol: OSU-18035

    Principal Investigator: Robert A Baiocchi, MD, PhD

    Learn More
  • open for enrollment

    Ph2 Bruton's Tyrosine Kinase Inhibitor PCI-32765 for Treatment of Relapsed Hairy Cell Leukemia

    Protocol: OSU-12200

    Principal Investigator: Kerry Rogers, MD

    Learn More