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

• Conditions: platinum refractory or resistant ovarian cancer; MedDRA version: 8.1Level: LLTClassification code 10033160

• Registration Number: EUCTR2006-000366-36-BE
• Lead Sponsor: Telik, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 244

Inclusion Criteria

1. Considered platinum refractory or resistant according to standard criteria.

2. Histologically or cytologically confirmed epithelial cancer of the ovary, fallopian tube or primary peritoneal cancer.

3. Measurable disease including at least one measurable lesion according to RECIST criteria with documented tumor progression before study entry or disease that has not responded to treatment.

4. Female = 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment with chemotherapy other than a platinum-based regimen.

2. Treatment with more than two platinum-based regimens.

3. Clinically significant cardiac disease.

4. Any signs of intestinal obstruction interfering with nutrition.

5. Pregnant or lactating women.

6. History of prior liposomal doxorubicin or anthracycline chemotherapy for ovarian cancer.

7. History of prior TLK286 (Telcyta™) therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate superiority in progression-free survival (PFS) of TLK286 (Telcya) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to active control therapy with liposomal doxorubicin (Doxil/Caeylx);Secondary Objective: To demonstrate superiority in the objective response rate (ORR) of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caeylx) as compared to active control therapy with liposomal doxorubicin (Doxil/Caelyx).;Primary end point(s): Objective response rates (ORR) based on RECIST criteria.