Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05012397
Status:
TERMINATED
Last Update Posted:
2023-10-18
First Post:
2021-08-13
Brief Title:
Milademetan in AdvancedMetastatic Solid Tumors
Sponsor:
Rain Oncology Inc
Organization:
Rain Oncology Inc
Study Overview
Official Title:
A Phase 2 Basket Study of Milademetan in AdvancedMetastatic Solid Tumors MANTRA-2
Status:
TERMINATED
Status Verified Date:
2024-10
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:
None
Brief Summary:
Phase 2 multicenter single-arm open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type WT TP53 and MDM2 copy number CN 8 using prespecified biomarker criteria
Detailed Description:
Approximately 65 patients will be enrolled to receive milademetan
Patients will receive the study drug until reaching unequivocal disease progression per Response Evaluation Criteria in Solid Tumors RECIST version 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 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 the study drug whichever comes first
Patients will receive the study drug until reaching unequivocal disease progression per Response Evaluation Criteria in Solid Tumors RECIST version 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 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 the 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