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

This study has been completed.

Sponsor:

Information provided by:

Telik

ClinicalTrials.gov Identifier:

NCT00052065

First received: January 21, 2003

Last updated: July 21, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 21, 2003
Last Updated Date	July 21, 2011
Start Date ^ICMJE	February 2003
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00052065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Official Title ^ICMJE	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: TLK286
Study Arm (s)	Not Provided
Publications *	Kavanagh JJ, Levenback CF, Ramirez PT, Wolf JL, Moore CL, Jones MR, Meng L, Brown GL, Bast RC Jr. Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer. J Hematol Oncol. 2010 Mar 11;3:9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	March 2006
Primary Completion Date	March 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00052065
Other Study ID Numbers ^ICMJE	TLK286.2011
Has Data Monitoring Committee	Not Provided
Responsible Party	Gail Brown, M.D. Chief Medical Officer, Telik, Inc.
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Telik
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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