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TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00052065
First Posted: January 23, 2003
Last Update Posted: July 25, 2011
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.
Information provided by:
Telik
  Purpose
This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant 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 Doxil in Platinum Refractory or Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Telik:

Estimated Enrollment: 28
Study Start Date: February 2003
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 cancer or primary peritoneal cancer
  • Recurrent epithelial ovarian cancer or persistent disease following primary treatment
  • At least one, but no more than four, prior platinum-containing chemotherapy regimens
  • At least one prior taxane-containing regimen

Exclusion Criteria

  • A 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 the patient has been disease-free for 2 years
  • Known leptomeningeal metastases or carcinomatous meningitis
  • Have received prior Doxil or other liposomal doxorubicin
  • Having received whole pelvis radiation therapy
  Contacts and Locations
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): NCT00052065


Locations
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Telik
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
ClinicalTrials.gov Identifier: NCT00052065     History of Changes
Other Study ID Numbers: TLK286.2011
First Submitted: January 21, 2003
First Posted: January 23, 2003
Last Update Posted: July 25, 2011
Last Verified: June 2011

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