drugset / Trial / NCT02004093
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.
Timeline
- Start
- 2005-12
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Chemotherapy + Pertuzumab vs Chemotherapy; p = 0.3967; Log Rank NCT02004093 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
| Background | Carboplatin | Small molecule | 4 unknown | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |