A phase II, open-label, controlled, randomized, multicenter study to evaluate the efficacy and safety of pertuzumab Omnitarg , a recombinant humanized antibody against HER2, in combination with carboplatin-based standard chemotherapy versus carboplatin-based standard chemotherapy alone in patients with platinum-sensitive recurrent ovarian cancer
- Conditions
- Platinum-sensitive recurrent ovarian cancer, which is defined by a progression-free interval of greater than 6 months after completion of platinum-based chemotherapy.MedDRA version: 6.1Level: PTClassification code 10033128
- Registration Number
- EUCTR2005-000557-30-IT
- Lead Sponsor
- ROCHE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 148
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method