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NCT00055250 Clinical Trial

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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00055250
Other study ID # 4840
Secondary ID H6H-MC-JEAL
Status Completed
Phase Phase 2
First received February 21, 2003
Last updated January 24, 2007
Start date January 2003
Est. completion date October 2005

Study information
Verified date January 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date October 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gemcitabine

• LY293111

• placebo

Locations
Country Name City State
United States 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. Lakeland Florida

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6-month survival
Secondary Toxicity
Secondary tumor response
Secondary PK
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