26 septiembre 2016

Yondelis Nueva Fase III . Istituto Nazionale del Tumori ( Milano ) Comunica el Inicio de la Fase 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 (Mito23) .

ClinicalTrials Identifier: NCT02903004
Updated: 2016_09_15 .
Resultado de imagen de istituto tumori milano

Descriptive Information

Brief titleTrial 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 .

Official titleRandomized 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 .

Brief 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


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Administrative Data

Organization nameFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Organization study IDINT 181/15
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
Health AuthorityItaly: The Italian Medicines Agency .