At a glance
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A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression
In Brief
A Phase 3 clinical trial evaluating Gemcitabine (Chemotherapy), Paclitaxel (Chemotherapy), and 3 other interventions for Ovarian Cancer. Completed, enrolled 208 participants across 68 sites in 10 countries.
Detailed Summary
This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).
Study Details
Timeline
Interventions
Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
Participants administered paclitaxel at a dosage of 80 mg/m\^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
Participants administered topotecan at a dosage of 1.25 mg/m\^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.