Conditions: Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer
Keywords: Omnitarg Cancer Platinum-Resistant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

Detailed description:

Arms:
arm 1: Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). arm 2: Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m\^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles

Interventions: intervention 1: Placebo intervention 2: Gemcitabine intervention 3: Pertuzumab
Intervention descriptions: intervention 1: Placebo was provided as a single-use formulation for infusion. intervention 2: Gemcitabine was provided as a solution for infusion. intervention 3: Pertuzumab was provided as a single-use formulation for infusion.

Protocol document: