TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	January 21, 2003
Last Updated Date	January 10, 2008
Start Date ^ICMJE	January 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00052065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: TLK286
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date
Primary Completion Date
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 ID ^ICMJE	NCT00052065
Responsible Party
Study ID Numbers ^ICMJE	TLK286.2011
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Telik
Verification Date	February 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP