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TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

This study has been completed.
Information provided by:
Telik Identifier:
First received: January 17, 2003
Last updated: July 21, 2011
Last verified: February 2007
This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.

Condition Intervention Phase
Ovarian Neoplasms Drug: TLK286 Phase 1 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 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by Telik:

Estimated Enrollment: 28
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)

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

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
  • Recurrent ovarian cancer or persistent disease following primary treatment
  • At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
  • At least 18 years of age

Exclusion Criteria

  • Pregnant or lactating women
  • History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which patient has been disease-free for at least 2 years
  • Known leptomeningeal metastases or carcinomatous meningitis
  • Having received whole pelvis radiation therapy
  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: NCT00051948

United States, California
Santa Monica Hematology/Oncology Consultants
Santa Monica, California, United States, 90404
United States, Illinois
Midwest Cancer Research Group, Inc.
Skokie, Illinois, United States, 60077
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information

Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc. Identifier: NCT00051948     History of Changes
Other Study ID Numbers: TLK286.2018
Study First Received: January 17, 2003
Last Updated: July 21, 2011

Additional relevant MeSH terms:
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
Antineoplastic Agents processed this record on September 21, 2017