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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

January 17, 2003
July 21, 2011
January 2003
January 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00051948 on ClinicalTrials.gov Archive Site
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TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent Ovarian Cancer

This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent ovarian cancer.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
Drug: TLK286
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00051948
TLK286.2018
Not Provided
Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
Telik
Not Provided
Not Provided
Telik
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP