A Study for Participants With Pancreatic Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pancreatic Neoplasms

Clinical Trial Details

NCT number	NCT00839332
Study type	Interventional
Source	Eli Lilly and Company
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	February 2009
Completion date	December 2013

View Details

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