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Phase 2 Study of TLK286 in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00035841
First received: May 6, 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 treatment of metastatic breast cancer.


Condition Intervention Phase
Breast Neoplasms
 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
Official Title: Phase 2 Study of TLK286 in Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telik:

Estimated Enrollment: 60
Study Start Date: April 2002
Study Completion Date: July 2004
Primary Completion Date: July 2004 (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 diagnosis of breast cancer
  • Metastatic disease
  • Measurable or evaluable disease
  • No prior chemotherapy regimens
  • Age at least 18 years
  • Adequate liver and kidney function
  • Adequate bone marrow function

Exclusion Criteria:

  • Pregnant or lactating women
  • Unstable medical conditions
  • Chemotherapy within 14 days of TLK286
  • Radiation therapy within 14 days of TLK286
  • Hormonal therapy within 14 days of TLK286
  • Immunotherapy within 14 days of TLK286
  • CNS metastasis unless controlled by treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035841

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Telik
  More Information

No publications provided

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00035841     History of Changes
Other Study ID Numbers: TLK286.2008
Study First Received: May 6, 2002
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013