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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

NCT02903004 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2021-08-25

No results posted yet for this study

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

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Trabectedin

DRUG

Pegylated Liposomal Doxorubicin

DRUG

Topotecan

DRUG

Gemcitabine

DRUG

Weekly Paclitaxel

DRUG

Carboplatin

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Domenica Lorusso, Prof. · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-11
Primary Completion
2018-12-20
Completion
2018-12-20

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02903004 on ClinicalTrials.gov