An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PharmaMar
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Trabectedin

Criteria

Inclusion Criteria:

• Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer

• Prior treatment with only 1 platinum based chemotherapy regimen

• Eastern Cooperative Oncology Group status of not more than 2

• Progression more than 6 months after the start of initial chemotherapy treatment

Exclusion Criteria:

• Treatment with more than 1 prior chemotherapy regimen

• Progression within 6 months after starting initial chemotherapy

• Prior exposure to anthracyclines

• Unwilling or unable to have central venous catheter

• Known clinically relevant central nervous system metastasis