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

This study has been completed.

First Received on March 26, 2004. Last Updated on January 10, 2008 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00080340

Purpose

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.

Condition	Intervention	Phase
Non Small Cell Lung Carcinoma	Drug: TLK286 (Telcyta) HCl for Injection Drug: gefitinib (Iressa)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment:	520
Estimated Study Completion Date:	May 2005

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080340

Show 339 Study Locations

Sponsors and Collaborators

Telik

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00080340 History of Changes
Other Study ID Numbers:	TLK286.3020
Study First Received:	March 26, 2004
Last Updated:	January 10, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012