Conditions: Ovarian Neoplasms Peritoneal Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1366
Healthy volunteers: no

Brief summary:
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.

Detailed description:

Arms:
arm 1: patients to receive BIBF 1120 standard dose twice daily PO in combination with combination with carboplatin and paclitaxel arm 2: patients to receive capsules identical to those containing BIBF 1120 in combination with combination with carboplatin and paclitaxel

Interventions: intervention 1: Placebo intervention 2: Paclitaxel intervention 3: BIBF 1120 intervention 4: Carboplatin intervention 5: Paclitaxel intervention 6: Carboplatin
Intervention descriptions: intervention 1: comparator to BIBF 1120 intervention 2: Paclitaxel (standard chemo-therapy) intervention 3: comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin) intervention 4: Carboplatin (standard chemo-therapy) intervention 5: Paclitaxel (standard chemo-therapy) intervention 6: Carboplatin (standard chemo-therapy)

Protocol document: