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

This study has been completed.
Sponsor:
Information provided by:
Telik
ClinicalTrials.gov Identifier:
NCT00051948
First received: January 17, 2003
Last updated: July 21, 2011
Last verified: February 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Carboplatin
U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051948

Locations
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
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
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: NCT00051948     History of Changes
Other Study ID Numbers: TLK286.2018
Study First Received: January 17, 2003
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
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013