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 (MITO23)
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|ClinicalTrials.gov Identifier: NCT02903004|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2016
Last Update Posted : July 24, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: Trabectedin Drug: Pegylated Liposomal Doxorubicin Drug: Topotecan Drug: Gemcitabine Drug: Weekly Paclitaxel Drug: Carboplatin||Phase 3|
Subjects will be randomized in a 1:1 ratio to receive one of the following treatments: Arm A: Trabectedin 1.3 mg/m2 d1 q 21 in 3 hours (central line) Arm B: Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/ m2 dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 Weekly Paclitaxel 80 mg/ m2 dd 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28 Randomization will be stratified based on platinum-free interval (PFI) (PFI ≥ 0 and ≤ 6 months vs. PFI > 6 months), presence / absence of measurable disease/number of previous chemotherapy lines, germline BRCA mutational status vs BRCAness phenotype.
Platinum-free interval (PFI) is defined as the time from the last dose of the platinum containing regimen until the first date progression.
Subjects will continue to receive chemotherapy treatment until disease progression (clinical progression meant as global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression is considered progression of disease), intolerability, patient refusal, investigator decision or death from any cause.
Subjects will be evaluated every 12 weeks ± 1 week by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for objective radiographic response and radiographic disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||April 11, 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Trabectedin 1.3 mg/m2 d1 q 21 in 3 hours (central line)
Other Name: Yondelis
Pegylated Liposomal Doxorubicin 40 mg/mq q 28 or Topotecan 4 mg/ m2 dd 1,8,15 q 28 or Gemcitabine 1000 mg/mq dd 1, 8, 15 q 28 Weekly Paclitaxel 80 mg/ m2 dd 1, 8, 15 q 28 Carboplatin AUC 5-6 q 21 or 28
Drug: Pegylated Liposomal Doxorubicin
Drug: Weekly Paclitaxel
- Overall Survival (OS) [ Time Frame: 4 years ]The primary objective is to compare the Trabectedin versus physician' choice chemotherapy in terms of overall survival (OS).
- Progression free survival (PFS) [ Time Frame: 4 years ]Progression-free survival [the diagnosis of progression will be assessed by radiological criteria; CA 125 increases alone (GCIG criteria of progression) will not be considered as progression of disease without a radiological confirmation of progression].
- Duration of Response [ Time Frame: 4 years ]Duration of response
- Adverse events [ Time Frame: 4 years ]Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903004
|Rome, Italy, 00168|
|Principal Investigator:||Domenica Lorusso, Prof.||Fondazione Policlinico Universitario A. Gemelli, IRCCS|