A Study for Participants With Pancreatic Cancer

A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer

The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment for participants with pancreatic cancer.

Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared (mg/m^2) to 250 mg/m^2 divided into 5 cohorts. Each participant was assigned to a single cohort with no intra-participant dose escalation. Phase 1 also included an expansion cohort where participants received a flat dose of 200 or 230 mg LY2603618. Participants received gemcitabine on Days 1, 8, and 15, followed by LY2603618 on Days 2, 9, and 16 of each 28-day cycle. The purpose of the Phase 1 portion was to determine the maximum tolerated LY2603618 dose to be carried into the Phase 2 portion of the study.

Inclusion Criteria:

• Diagnosed with cancer that is metastatic and/or advanced during Phase 1
• Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
• Must be at least 18 years of age
• Adequate hematological, liver, and renal functions
• Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Exclusion Criteria:

• Known hypersensitivity to gemcitabine
• Pregnant or lactating females or refusal to use medically approved contraceptive precautions
• Had prior treatment with radiotherapy involving more than 25% of marrow producing area
• Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry