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

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.
 
ClinicalTrials.gov Identifier: NCT00051948
Recruitment Status : Completed
First Posted : January 22, 2003
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:
Telik

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: TLK286 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 28 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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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): NCT00051948


Locations
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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
Telik
More Information
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Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00051948    
Other Study ID Numbers: TLK286.2018
First Posted: January 22, 2003    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: February 2007
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders