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Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00040638
First received: July 2, 2002
Last updated: July 21, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.


Condition Intervention Phase
Carcinoma, Non-small-cell Lung
 Drug: TLK286
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment: 40
Study Start Date: July 2002
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040638

Locations
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
Telik
  More Information

No publications provided

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00040638     History of Changes
Other Study ID Numbers: TLK286.2014
Study First Received: July 2, 2002
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013