Back to resultsA Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
LY293111
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
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
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Outcomes
Primary Outcome Measures
6-month survival
Secondary Outcome Measures
Toxicity
tumor response
PK
Full Information
NCT ID
NCT00055250
First Posted
February 21, 2003
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00055250
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
LY293111
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
6-month survival
Secondary Outcome Measure Information:
Title
Toxicity
Title
tumor response
Title
PK
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Lakeland
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer
We'll reach out to this number within 24 hrs