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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 26 May 2017

At a glance

  • Drugs Pertuzumab (Primary) ; Gemcitabine; Paclitaxel; Topotecan
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PENELOPE
  • Sponsors Roche
  • Most Recent Events

    • 05 Jul 2016 Status changed from active, no longer recruiting to completed.
    • 05 Jul 2016 Time frame for primary endpoint has been changed; a treatment arm has been added.
    • 06 Jun 2016 Results published in the Journal of Clinical Oncology
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