A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

October 2, 2003

Last Updated Date

December 17, 2007

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To determine if progression-free survival in patients with Stage IIIB or IV NSCLC receiving gemcitabine and cisplatin can be improved by adding 200 or 600 mg BID of LY293111 as compared to placebo.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00069875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure)
tumor response rate
toxicity rates
exposure-response relationship
quality of life

Original Secondary Outcome Measures ^ICMJE

-time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure)
-tumor response rate
-toxicity rates
-exposure-response relationship
-quality of life

Descriptive Information

Brief Title ^ICMJE

A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer

Official Title ^ICMJE

Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of Gemcitabine-Cisplatin Combined With Two Different Doses of LY293111 or Placebo in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Brief Summary

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: Gemcitabine
Drug: LY293111
Drug: cisplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

195

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-Small Cell Lung Cancer, Stage IIIB or IV that is not amenable to either surgery of curative intent or radiation therapy
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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Germany, Israel, Netherlands, Spain

Administrative Information

NCT ID ^ICMJE

NCT00069875

Responsible Party

Study ID Numbers ^ICMJE

4842, H6H-MC-JEAM

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP