Conditions: Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: Ovarian Cancer Platinum-resistant Platinum-refractory Fallopian tube cancer Peritoneal Cancer Paclitaxel ErbB3 Phase II locally advanced/metastatic or recurrent
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 223
Healthy volunteers: no

Brief summary:
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone

Detailed description:
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.

Arms:
arm 1: Standard dosing paclitaxel: 80 mg/m2 QW intravenously) arm 2: administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses

Interventions: intervention 1: MM-121 intervention 2: Paclitaxel
Intervention descriptions: intervention 1: MM-121 (SAR256212) (IV) intervention 2: Standard dosing Paclitaxel (IV)

Protocol document: