Conditions: Ovarian Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 2
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. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.

Detailed description:

Arms:
arm 1: BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2) arm 2: BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2) arm 3: BIBF 1120 (high dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)

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

Protocol document: