Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04979442
Status:
TERMINATED
Last Update Posted:
2023-10-18
First Post:
2021-07-06
Brief Title:
Treatment of Milademetan Versus Trabectedin in Patient With Dedifferentiated Liposarcoma
Sponsor:
Rain Oncology Inc
Organization:
Rain Oncology Inc
Study Overview
Official Title:
A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANTRA
Brief Summary:
Randomized multicenter open-label Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable ie where resection is deemed to cause unacceptable morbidity or mortality or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies including at least 1 anthracycline-based therapy
Detailed Description:
Approximately 160 patients will be randomly assigned in a 11 ratio to receive milademetan or trabectedin Randomization will be stratified by the ECOG performance status 0 or 1 and number of prior treatments 2 or 2 for the patients liposarcoma
Patients will receive study drug ie milademetan or trabectedin until reaching unequivocal disease progression RECIST v11 as determined by the Investigator experiencing unmanageable toxicity or until other treatment discontinuation criteria are met Patients may be treated beyond tumor progression if they are experiencing clinical benefit based on the assessment of the Investigator in discussion with the Medical Monitor All patients will be followed for documentation of disease progression and survival information ie date and cause of death and subsequent treatment information ie dateduration of treatment response and subsequent disease progression Long-term follow-up will continue every 12 weeks 7 days until the endpoint of death the patient is lost to follow-up or for 24 months following the final dose of study drug whichever comes first
Patients will receive study drug ie milademetan or trabectedin until reaching unequivocal disease progression RECIST v11 as determined by the Investigator experiencing unmanageable toxicity or until other treatment discontinuation criteria are met Patients may be treated beyond tumor progression if they are experiencing clinical benefit based on the assessment of the Investigator in discussion with the Medical Monitor All patients will be followed for documentation of disease progression and survival information ie date and cause of death and subsequent treatment information ie dateduration of treatment response and subsequent disease progression Long-term follow-up will continue every 12 weeks 7 days until the endpoint of death the patient is lost to follow-up or for 24 months following the final dose of study drug whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None