Ph 3 Randomized Study of Telcyta® + Liposomal Doxorubicin Vs Liposomal Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Telik

ClinicalTrials.gov Identifier:

NCT00350948

First received: July 6, 2006

Last updated: May 30, 2012

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 6, 2006
Last Updated Date	May 30, 2012
Start Date ^ICMJE	May 2006
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 13, 2011)	To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxirubicin as compared with the active control arm liposomal doxorubicin [ Time Frame: Once 244 planned pts. received at least 2 cycles of study treatment(s) ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00350948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 13, 2011)	To evaluate and compare the safety profile of each treatment arm [ Time Frame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety. ] [ Designated as safety issue: Yes ]
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	Ph 3 Randomized Study of Telcyta® + Liposomal Doxorubicin Vs Liposomal Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
Official Title ^ICMJE	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)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: TLK286 (Telcyta) HCI for Injection Day 1 of 28 day Cycle. Drug: Doxorubicin HCI Liposome Injection Day 1 of 28 Day Cycle. 50 mg/m2
Study Arm (s)	Experimental: TLK286 (Telcyta) in Combination with Liposomal Doxorubcin Intervention: Drug: TLK286 (Telcyta) HCI for Injection Active Comparator: Liposomal Doxorubcin (doxil/Caelyx) FDA Approved Regimen Intervention: Drug: Doxorubicin HCI Liposome Injection
Publications *	Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80.
* 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	244
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Are a woman 18 years of age or older Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer Have platinum refractory or resistant cancer Measurable disease according to radiographic RECIST criteria progression Exclusion Criteria: Had treatment with first-line chemotherapy other than a platinum-containing regimen Have clinically significant cardiac disease Have any sign of intestinal obstruction interfering with nutrition Are pregnant or lactating Had prior treatment with liposomal doxorubicin Had prior treatment with Telcyta
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, Belgium, Brazil, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00350948
Other Study ID Numbers ^ICMJE	TLK286.3025
Has Data Monitoring Committee	Not Provided
Responsible Party	Telik
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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