Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients

• Status: Completed
• Trial end date: 2018-12-20

Summary

This is an open-label, prospective, multicenter, randomized Phase III, clinical trial evaluating the efficacy and safety of trabectedin in BRCA1 and BRCA2 mutation carrier and BRCAness phenotype advanced ovarian cancer patients in comparison to physician' choice chemotherapy.

Arm A: Trabectedin 1.3 mg/mq d1 q 21 in 3 hours (central line) Arm B: Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/mq dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 Weekly Paclitaxel 80 mg/mq gg 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28

Patients will be randomly assigned in a 1:1 ratio to treatment arms. During the randomization process, patients will be stratified by

• Platinum sensitivity

• Measurable disease

• Number of previous chemotherapy lines > vs < 3

• BRCA mutational status

• Phase: Phase 3

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Treatments: Carboplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Paclitaxel; Topotecan; Trabectedin