A Study for Patients With Advanced Cancer

• Number of participants with clinically significant effects [ Time Frame: Baseline to study completion ] [ Designated as safety issue: Yes ]
• Pharmacokinetics, maximum concentration (Cmax) [ Time Frame: Baseline, Days 1, 3 of Cycles 1 and 2 ] [ Designated as safety issue: No ]
• Number of participants with tumor response [ Time Frame: Baseline to measured disease progression or discontinuation ] [ Designated as safety issue: No ]
• Pharmacokinetics, area under the concentration-time curve (AUC) [ Time Frame: Baseline, Days 1, 3 of Cycles 1 and 2 ] [ Designated as safety issue: No ]

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).

This study is a multi-center, non-randomized, open label, dose-escalation, Phase 1 study of intravenous LY2523355 in patients with advanced and/or metastatic cancer (including Non-Hodgkin's Lymphoma) for whom no treatment of higher priority exists.

• Advanced Cancer
• Metastatic Cancer

• Drug: LY2523355
  Administered intravenously 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 0.125mg/m2.
• Drug: LY2523355
  Administered intravenously 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 4mg/m2.
• Drug: pegfilgrastim
  6 mg administered subcutaneously on day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.

• Experimental: LY2523355
  Intervention: Drug: LY2523355
• Experimental: LY2523355 + pegfilgrastim
  Interventions:

  • Drug: LY2523355
  • Drug: pegfilgrastim

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
• Females who are pregnant or lactating
• Known hypersensitivity to pegfilgrastim or filgrastim