Overview

A Study for Participants With Pancreatic Cancer

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Gemcitabine
Criteria
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