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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.
Information provided by:
Telik Identifier:
First received: March 26, 2004
Last updated: January 10, 2008
Last verified: March 2006
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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00080340

  Show 339 Study Locations
Sponsors and Collaborators
  More Information Identifier: NCT00080340     History of Changes
Other Study ID Numbers: TLK286.3020
Study First Received: March 26, 2004
Last Updated: January 10, 2008

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 processed this record on August 18, 2017