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

This study has been completed.

First Received on July 2, 2002. Last Updated on July 21, 2011 History of Changes

Sponsor:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00040638

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 II

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 February 12, 2012