Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Information provided by:

Telik

ClinicalTrials.gov Identifier:

NCT00080340

First received: March 26, 2004

Last updated: January 10, 2008

Last verified: March 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	March 26, 2004
Last Updated Date	January 10, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title ^ICMJE	Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Brief Summary	The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Non Small Cell Lung Carcinoma
Intervention ^ICMJE	Drug: TLK286 (Telcyta) HCl for Injection Drug: gefitinib (Iressa)
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	520
Completion Date	May 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Clinical diagnosis of non-small cell lung cancer Non-small cell lung cancer that is not curable with surgery, radiation, or combined modality chemoradiation Failed two prior chemotherapy regimens which must have included platinum Measurable disease Exclusion Criteria: Treatment with more than two prior chemotherapy regimens History of bone marrow transplantation or stem cell support Pregnant or lactating women Known history of prior gefitinib therapy Known history of prior TLK286 therapy
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Australia, Brazil, Chile, Germany, Italy, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00080340
Other Study ID Numbers ^ICMJE	TLK286.3020
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Telik
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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