Conditions: Ovarian Neoplasms Peritoneal Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: no

Brief summary:
This phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer.

Detailed description:

Arms:
arm 1: BIBF 1120 (100 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2) arm 2: BIBF 1120 (150 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2) arm 3: BIBF 1120 (200 mg twice daily (BID)) + Carboplatin (Area Under the Curve (AUC) 5 mg/mL\*min) + PLD (30 mg/m2)

Interventions: intervention 1: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 2: BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min intervention 3: BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
Intervention descriptions: intervention 1: BIBF1120 twice daily along with standard therapy of PLD + carboplatin intervention 2: BIBF1120 twice daily along with standard therapy of PLD + carboplatin intervention 3: BIBF1120 twice daily along with standard therapy of PLD + carboplatin

Protocol document: