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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000366-36-GB
Enrollment
244
Registered
2006-02-13
Start date
2006-06-07
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

platinum refractory or resistant ovarian cancer MedDRA version: 8.1 Level: LLT Classification code 10033160

Interventions

Product Name: TLK286 for Injection (Telcyta™) Product Code: TLK286, TER 286, AMRI 50,061 Pharmaceutical Form: Concentrate for solution for infusion INN

Sponsors

Telik, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate superiority in the objective response rate of TLK286 in combination with liposomal doxorubicin as compared to active control therapy with liposomal doxorubicin.; Secondary Objective: 1. To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared to active control therapy with liposomal doxorubicin. 2. To evaluate and compare the safety profile of each treatment arm. 3. To evaluate and compare survival on each treatment arm. ;Primary end point(s): Objective response rates (ORR) based on RECIST criteria.—

Countries

Belgium, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026