A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer - Tabular View

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A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer

This study has been completed.
Information provided by Eli Lilly and Company

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer

Official Title ^†

A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of Gemcitabine Plus LY293111 Compared to Gemcitabine Plus Placebo in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Brief Summary

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients with pancreatic cancer.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

6-month survival

Secondary Outcome Measure ^†

Toxicity
tumor response
PK

Condition ^†

Pancreatic Cancer

Intervention ^†

Drug: Gemcitabine
Drug: LY293111
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

130

Start Date ^†

January 2003

Completion Date

October 2005

Eligibility Criteria ^†

Inclusion Criteria:

Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent
Tumor that can be measured by x-ray or scan
Adequate organ function

Exclusion Criteria:

Inability to swallow capsules
Documented brain metastases
Prior chemotherapy or biological therapy for this disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00055250

Organization ID

4840

Secondary IDs ^††

H6H-MC-JEAL

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

First Received Date ^†

February 21, 2003

Last Updated Date

January 24, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.