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Phase 2 Study of TLK286 in Metastatic Breast Cancer

This study has been completed.
Information provided by:
Telik Identifier:
First received: May 6, 2002
Last updated: July 21, 2011
Last verified: June 2011
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of TLK286 in Metastatic Breast Cancer

Resource links provided by NLM:

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00035841

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
  More Information

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc. Identifier: NCT00035841     History of Changes
Other Study ID Numbers: TLK286.2008
Study First Received: May 6, 2002
Last Updated: July 21, 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 25, 2017