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

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00038428
First received: May 30, 2002
Last updated: July 21, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00038428     History of Changes
Other Study ID Numbers: TLK286.2003
Study First Received: May 30, 2002
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013