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Phase 2 Study of TLK286 in Platinum Resistant Advanced Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038428
First Posted: May 31, 2002
Last Update Posted: July 25, 2011
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.
Information provided by:
Telik
  Purpose
The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every week in the treatment of patients with advanced ovarian cancer that is resistant to platinum-based chemotherapy.

Condition Intervention Phase
Ovarian 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

Resource links provided by NLM:


Further study details as provided by Telik:

Estimated Enrollment: 40
Study Start Date: June 2001
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria

  • Histologic diagnosis of ovarian cancer
  • Recurrent or persistent disease following primary therapy
  • Measurable disease
  • Prior treatment with at least one but no more than three prior chemotherapy regimens
  • Resistant or refractory to platinum-based chemotherapy
  • At least 18 years of age
  • Good performance status (ECOG 0 to 1)
  • Adequate liver, renal and bone marrow function

Exclusion criteria

  • Pregnant or currently breast feeding
  • Treatment with chemotherapy or immunotherapy within four weeks
  • Prior radiation to the whole pelvis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00038428


Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Telik
  More Information

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00038428     History of Changes
Other Study ID Numbers: TLK286.2003
First Submitted: May 30, 2002
First Posted: May 31, 2002
Last Update Posted: July 25, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders