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

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

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00055250

Purpose

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	Intervention	Phase
Pancreatic Cancer	Drug: Gemcitabine Drug: LY293111 Drug: placebo	Phase II

MedlinePlus related topics:

Cancer Pancreatic Cancer

ChemIDplus related topics:

Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

6-month survival

Secondary Outcome Measures:

Toxicity
tumor response
PK

Estimated Enrollment:	130
Study Start Date:	January 2003
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055250

Locations


United States, Florida
	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

More Information

Study ID Numbers:	4840, H6H-MC-JEAL
First Received:	February 21, 2003
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00055250
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Pancreatic Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Gastrointestinal Neoplasms

Endocrinopathy

Gemcitabine

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on July 18, 2008