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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

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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 No
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.




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