Loading clinical trials...
Loading clinical trials...
Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.
This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Desert Oasis Cancer Center
Casa Grande, Arizona, United States
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
East Bay Medical Oncology/Hematology Medical Associates, Inc.
Antioch, California, United States
Bay Area Cancer Research Group, LLC
Concord, California, United States
East Bay Medical Oncology/Hematology Medical Associates
Concord, California, United States
California Oncology of the Central Valley
Fresno, California, United States
Women's Cancer Research Foundation
Newport Beach, California, United States
Southwest Cancer Care
Poway, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Start Date
May 1, 2006
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2008
Last Updated
November 27, 2013
244
ACTUAL participants
Telcyta
DRUG
Liposomal Doxorubicin
DRUG
Lead Sponsor
Telik
NCT07213804
NCT06051695
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions