drugset / Trial / NCT01735071
Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
Phase 2
Completed
71 enrolled
Mario Negri Institute for Pharmacological Research
Hoffmann-La Roche · collabPharmaMar · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is aimed at assessing the efficacy and the safety of the combination of bevacizumab and trabectedin with or without carboplatin in adult women with epithelial ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or second) platinum-containing regimen. According to the Bryant and Day design the primary endpoints will be the proportion of progression-free patients at 6 months for the efficacy, and the proportion of patients with severe toxicity for the safety at the same time-point.
Timeline
- Start
- 2013-07
- Primary completion
- 2018-03-18
- Completion
- 2018-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Carboplatin | Small molecule | 4 unknown | — |
| Subject | Trabectedin | Small molecule | 0.8 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.1 mg/m2 | Intravenous |