Status:
COMPLETED
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PharmaMar
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a multicenter, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), Phase 3 study comparing the combination of trabectedin + DOXI...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT00113607
Start Date
April 1 2005
End Date
November 1 2010
Last Update
June 27 2014
Active Locations (111)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile, Alabama, United States
2
Tucson, Arizona, United States
3
Los Angeles, California, United States
4
Newport Beach, California, United States