Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05130866
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2021-11-10
Brief Title:
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 NF2 Mutated Meningiomas
Sponsor:
Recursion Pharmaceuticals Inc
Organization:
Recursion Pharmaceuticals Inc
Study Overview
Official Title:
A Two-staged Phase 23 Randomized Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants With Progressive NF2 Mutated Meningiomas
Status:
RECRUITING
Status Verified Date:
2024-02
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:
POPLAR-NF2
Brief Summary:
This is a two-staged Phase 23 randomized multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas
Detailed Description:
This is a two-staged Phase 23 randomized multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas with either NF2 disease-related meningioma or recurrent sporadic meningiomas that have NF2 mutations
Cohort A will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas and provide guidance for the dose in the confirmatory part of the study Cohort B The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas
In both cohorts there will be a screening period of up to 8 weeks a treatment period a 4-week safety follow-up period after the end of treatment and a 6-month post-study follow-up The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study At the end of the study period participants may be offered participation in an open-label extension OLE period
In Cohort A adult participants will be randomized to one of two dose levels of REC-2282
In Cohort B participants will be randomized to REC-2282 treatment dose to be determined from Cohort A arm or placebo arm in a ratio of 21
Cohort A will provide early data on efficacy and safety of REC-2282 in participants with progressive NF2 mutated meningiomas and provide guidance for the dose in the confirmatory part of the study Cohort B The purpose of Cohort B of the study is to assess the efficacy and safety of REC-2282 compared with placebo in participants with progressive NF2 mutated meningiomas
In both cohorts there will be a screening period of up to 8 weeks a treatment period a 4-week safety follow-up period after the end of treatment and a 6-month post-study follow-up The first 8 participants enrolled in Cohort A will complete a food effect run-in sub study At the end of the study period participants may be offered participation in an open-label extension OLE period
In Cohort A adult participants will be randomized to one of two dose levels of REC-2282
In Cohort B participants will be randomized to REC-2282 treatment dose to be determined from Cohort A arm or placebo arm in a ratio of 21
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