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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

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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 No
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.




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