A Study for Participants With Pancreatic Cancer

Lilly

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pancreatic Neoplasms

Treatments: Drug: LY2603618; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839332

12096

I2I-MC-JMMC (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 2 patient groups

LY2603618 + Gemcitabine

Experimental group

Description:

Participants participated in Phase 1 or 2. LY2603618 (Phase 1): 70 to 250 milligrams/meter squared (mg/m\^2) LY2603618 as a 1-hour continuous intravenous (IV) infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression (DP). Participants received LY2603618 as part of the dose escalation cohort (dose of 70, 105, 150, 200, or 250 mg/m\^2) or the expansion cohort (flat dose of 200 mg or 230 mg). LY2603618 (Phase 2): 230 mg LY2603618 as a 1-hour continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until DP. Gemcitabine (Phase 1 and 2): 1000 mg/m\^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until DP. Participants received gemcitabine 24 hours prior to LY2603618 administration.

Treatment:

Drug: LY2603618

Drug: Gemcitabine

Gemcitabine

Active Comparator group

Description:

Participants participated in Phase 2 only. Gemcitabine (Phase 2): 1000 mg/m\^2 gemcitabine as a 30-minute continuous IV infusion once per week for 3 weeks, followed by 1 week of rest. This 28-day cycle was repeated for a minimum of 2 cycles and/or until disease progression.

Treatment:

Drug: Gemcitabine