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

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

This study has been completed.

Study NCT00069875. Last updated on December 17, 2007. Information provided by Eli Lilly and Company

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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.

Secondary Outcome Measure ^†

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

Condition ^†

Carcinoma, Non-Small-Cell Lung

Intervention ^†

Drug: Gemcitabine
Drug: LY293111
Drug: cisplatin

MEDLINE PMIDs

Links

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

195

Start Date ^†

September 2003

Completion Date

December 2005

Eligibility Criteria ^†

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 ^††

Location Countries ^†

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

Administrative Information Fields

NCT ID ^†

NCT00069875

Organization ID

4842

Secondary IDs ^††

H6H-MC-JEAM

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

December 2007

First Received Date ^†

October 2, 2003

Last Updated Date

December 17, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.