A Study With LY293111, Gemcitabine and Placebo in Patients With Pancreatic Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00055250
Collaborator
(none)
130
1
33
3.9
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2003
Study Completion Date
:
Oct 1, 2005
Outcome Measures
Primary Outcome Measures
- 6-month survival []
Secondary Outcome Measures
- Toxicity []
- tumor response []
- PK []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | United States |
Sponsors and Collaborators
- Eli Lilly and Company
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00055250
Other Study ID Numbers:
- 4840
- H6H-MC-JEAL
First Posted:
Feb 24, 2003
Last Update Posted:
Jan 26, 2007
Last Verified:
Jan 1, 2007