Your journey
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More info
You can access this
clinical trial
if you have
Ovarian Neoplasms
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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

Provided treatments

  • Drug: Trabectedin
  • Drug: Pegylated Liposomal Doxorubicin
  • Drug: Topotecan
  • Drug: Gemcitabine
  • Drug: Weekly Paclitaxel
  • Drug: Carboplatin
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02903004. The sponsor of the trial is Fondazione IRCCS Istituto Nazionale dei Tumori, Milano and it is looking for 244 volunteers for the current phase.
Official trial title:
Randomized Phase III 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_MITO-23