Ignite Creation Date:
2024-05-06 @ 9:06 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02903004
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2016-08-26
Brief Title:
Trial on Trabectedin ET-743 vs Clinicians Choice Chemotherapy in Recurrent Ovarian Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Randomized Phase III Trial on Trabectedin ET-743 vs Clinicians Choice Chemotherapy in Recurrent Ovarian Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITO23
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 13 mgmq d1 q 21 in 3 hours central line Arm B Pegylated Liposomal Doxorubicin 40 mgmq q 28 or Topotecan 4 mgmq dd 1815 q 28 or Gemcitabine 1000 mgmq dd 1 8 15 q 28 Weekly Paclitaxel 80 mgmq gg 1 8 15 q 28 Carboplatin AUC 5-6 q 21 or 28
Patients will be randomly assigned in a 11 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
Arm A Trabectedin 13 mgmq d1 q 21 in 3 hours central line Arm B Pegylated Liposomal Doxorubicin 40 mgmq q 28 or Topotecan 4 mgmq dd 1815 q 28 or Gemcitabine 1000 mgmq dd 1 8 15 q 28 Weekly Paclitaxel 80 mgmq gg 1 8 15 q 28 Carboplatin AUC 5-6 q 21 or 28
Patients will be randomly assigned in a 11 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
Detailed Description:
Subjects will be randomized in a 11 ratio to receive one of the following treatments Arm A Trabectedin 13 mgm2 d1 q 21 in 3 hours central line Arm B Pegylated Liposomal Doxorubicin 40 mgmq q 28 or Topotecan 4 mg m2 dd 1815 q 28 or Gemcitabine 1000 mgmq 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 diseasenumber 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 11 for objective radiographic response and radiographic disease progression
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 11 for objective radiographic response and radiographic disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None