A Study for Participants With Advanced Cancer
Condition: Advanced Cancer; Metastatic Cancer
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: LY2523355; LY2523355; pegfilgrastim
Intervention description: Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day).; Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day.; 6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Metastatic Cancer; Cancer

Summary:

      This study is being conducted to determine the safety of LY2523355 for the treatment of
      advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's
             lymphoma) that is refractory to standard therapy or for which no proven effective
             therapy exists. Participants entering Part B of the study must also have a tumor that
             is safely amenable to serial biopsies

          -  Have the presence of measurable or nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors (RECIST, Therasse et al. 2000) or Revised
             International Working Group Lymphoma Response Criteria (Cheson et al. 2007)

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment

          -  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 urine or 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

        Exclusion Criteria:

          -  Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases.
             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 metastases is not required

          -  Have current acute or chronic leukemia

          -  Have had an autologous or allogenic bone marrow transplant

          -  Have the following conduction abnormalities: PR >250 milliseconds (msec), second
             degree or complete atrioventricular (AV) block, intraventricular conduction delay
             (IVCD) with QRS ≥120 msec, left branch bundle block (LBBB), right branch bundle block
             (RBBB), Wolf-Parkinson- White syndrome (WPW), left anterior fascicular block (LAFB),
             left posterior fascicular block (LPFB), or other conduction abnormality that in the
             opinion of the investigator would preclude safe participation in this study.

          -  Females who are pregnant or lactating

          -  Known hypersensitivity to pegfilgrastim or filgrastim