Phase 2 Study of TLK286 Administered Weekly in Advanced 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: NCT00040638
Recruitment Status : Completed
First Posted : July 4, 2002
Last Update Posted : July 25, 2011
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Brief Summary:
The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: TLK286 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2002
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

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:

  • Histologic or cytologic diagnosis of non-small cell lung carcinoma
  • Progressed while on or after treatment on platinum-based regimen
  • Patients may not have had more than one prior cytotoxic chemotherapy regimen
  • Stage IV or IIIB
  • Age at least 18 years
  • Adequate liver and kidney function
  • Adequate bone marrow function

Exclusion Criteria:

  • Pregnancy or lactation
  • Unstable medical conditions
  • Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of TLK286
  • CNS metastasis unless controlled by treatment

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): NCT00040638

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc. Identifier: NCT00040638     History of Changes
Other Study ID Numbers: TLK286.2014
First Posted: July 4, 2002    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases