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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080340
Recruitment Status : Completed
First Posted : March 30, 2004
Last Update Posted : January 15, 2008
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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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Carcinoma Drug: TLK286 (Telcyta) HCl for Injection Drug: gefitinib (Iressa) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00080340

  Show 339 Study Locations
Sponsors and Collaborators
Telik Identifier: NCT00080340     History of Changes
Other Study ID Numbers: TLK286.3020
First Posted: March 30, 2004    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: March 2006

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action