At a glance
ClinicalIndex Comparison Record- ✓Advanced, histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma
- ✓Platinum-resistant or refractory disease
- ✓Measurable disease or clinically/radiologically detectable disease
- ✓Representative tumor specimens (paraffin blocks or ≥12 unstained slides) for HER2 activation evaluation
- ✕Prior treatment with gemcitabine
- ✕Prior HER2 pathway inhibitors (trastuzumab, gefitinib, erlotinib, cetuximab, GW572016)
- ✕≥2 prior regimens for platinum-resistant disease or ≥2 non-platinum regimens for platinum-sensitive disease
- ✕History or clinical evidence of CNS or brain metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Pertuzumab (rhuMAb 2C4) in Combination With Gemcitabine and the Effect of Tumor-Based HER2 Activation in Subjects With Platinum-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
In Brief
A Phase 2 clinical trial evaluating Placebo, Gemcitabine, and 1 other intervention for Ovarian Cancer and 2 related conditions. Completed, enrolled 131 participants across 41 sites.
Detailed 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.
Study Details
Timeline
Interventions
Placebo was provided as a single-use formulation for infusion.
Gemcitabine was provided as a solution for infusion.
Pertuzumab was provided as a single-use formulation for infusion.