A Study of LY2584702 in Solid Tumors
Condition: Cancer
Intervention: LY2584702
Intervention description: Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.
Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Metastatic Cancer; p70s6 inhibitor

Summary:

      The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese
      patients with advanced and/or metastatic solid tumors for which no proven effective therapy
      exists.
    

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 (RECIST). Japanese patients 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 Lilly.

          -  Have adequate organ function including:

               -  Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x
                  10^9/liter (L), platelets greater than or equal to 100 x 10^9/L, and hemoglobin
                  greater than or equal to 9 gram/deciliter (g/dL) (transfusions are not allowed
                  prior to enrollment within 2 weeks).

               -  Hepatic: Bilirubin less than or equal to 1.5 times upper limit of normal (ULN),
                  alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate transaminase
                  (AST) less than or equal to 2.5 times ULN, or 5 times ULN for patients with
                  hepatic metastases. Patients with bone metastases may enter with alkaline
                  phosphatase values less than 5 times ULN, as long as other hepatic parameters
                  meet inclusion criteria.

               -  Renal: Serum creatinine less than or equal to 1.5 times ULN.

          -  Have a performance status of less than or equal to 2 on the Eastern Cooperative
             Oncology Group scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy prior to study enrollment and recovered
             from the acute effects of therapy.

          -  Have an estimated life expectancy of 12 weeks or greater

          -  Are able to swallow capsules

        Exclusion Criteria:

          -  Have received treatment within 4 weeks of the initial dose of study drug with a drug
             that has not received regulatory approval for any indication.

          -  Have serious preexisting medical conditions or serious concomitant systemic disorders
             that, in the opinion of the investigator, would preclude participation in this study.

          -  Prior clinical history of tuberculosis (patient doubt tuberculosis is screening
             required), and positive test results in hepatitis B surface antigen (HBSAg), or
             hepatitis C antibodies (HCAb) (screening required).

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis. Patients 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 patients without history of CNS metastasis
             is not required.

          -  Have hematologic malignancies, or lymphoma.