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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00080340
First Posted: March 30, 2004
Last Update Posted: January 15, 2008
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.
Information provided by:
Telik
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Telik:

Estimated Enrollment: 520
Estimated Study Completion Date: May 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00080340


  Show 339 Study Locations
Sponsors and Collaborators
Telik
  More Information

ClinicalTrials.gov Identifier: NCT00080340     History of Changes
Other Study ID Numbers: TLK286.3020
First Submitted: March 26, 2004
First Posted: March 30, 2004
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action