A Study of LY2584702 in Participants With Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: LY2584702
Intervention description: administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced cancer

Summary:

      The main purpose of this trial is to determine a recommended Phase 2 dose of LY2584702 that
      may be safely administered to participants with advanced/metastatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of advanced and/or metastatic
             cancer (solid tumors) that is refractory to standard therapy and/or therapies known to
             provide clinical benefit, or for which no standard therapy exists

          -  Have the presence of disease amenable to efficacy assessment as defined by the
             Response Evaluation Criteria in Solid Tumors. Participants who have advanced
             non-measurable disease with elevation of a validated tumor marker may be eligible, if
             discussed and agreed upon by the investigator and the sponsor

          -  Participants entering Part C of the study must have a tumor that is safely amenable to
             2 biopsies (one pre-treatment and one on-treatment biopsy for the same tumor).
             Participants in Part C of the study must agree to biopsy procedures at time of consent

          -  Have adequate hematologic, renal, and hepatic organ function

          -  Have a performance status of less than or equal to 2 on the Eastern Cooperative
             Oncology Group (ECOG) scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy (with the exception of continuing
             gonadotropic releasing hormone (GnRH) agonist therapy for participants with prostate
             cancer, or anti-estrogen therapy [for example, an aromatase inhibitor] for
             participants with breast cancer), or other investigational therapy for at least 3
             weeks (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and
             recovered from the acute effects of therapy

          -  Are reliable and willing to be available for the duration of the study and are willing
             to follow study procedures

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug

          -  Females with child bearing potential must have had a negative serum pregnancy test
             less than or equal to 7 days prior to the first dose of study drug

          -  Have an estimated life expectancy of greater than or equal to 12 weeks

          -  Are able to swallow capsules

        Exclusion Criteria:

          -  Have received treatment within 3 weeks of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication

          -  Have 1 or more serious preexisting medical conditions that, in the opinion of the
             investigator, would preclude participation in this study.

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Participants
             with treated CNS metastases are eligible provided their disease is radiographically
             stable, asymptomatic, and they are not currently receiving corticosteroids and/or
             anticonvulsants. Screening of asymptomatic participants without history of CNS
             metastasis is not required

          -  Have hematologic malignancies, or lymphoma

          -  Females who are pregnant or lactating

          -  Have a second primary malignancy that, in the judgement of the investigator and
             sponsor, may affect the interpretation of results

          -  Have bleeding diathesis