drugset / Trial / NCT01735071

Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer

NCT01735071

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

EvaluationDrugModalityDoseRoute
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