Viewing Study NCT06159166



Ignite Creation Date: 2024-05-06 @ 7:50 PM
Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06159166
Status: RECRUITING
Last Update Posted: 2024-04-25
First Post: 2023-11-08

Brief Title: Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 NF1 and Cutaneous Neurofibromas cNF
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: A Phase 12a Open-label Multicenter Dose Finding Study to Evaluate the Safety and Anti-tumor Activity of Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 NF1 and Cutaneous Neurofibromas cNF
Status: RECRUITING
Status Verified Date: 2024-04
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: Mirda
Brief Summary: This is a Phase 12a open-label non-randomized multi-dose study of mirdametinib monotherapy in adults with NF1 and cNF

In both Phases of the study participation in the study will comprise three periods screening treatment and post-study safety follow-up to be performed at the NF1 and cNF specialty center Johns Hopkins University
Detailed Description: This is a Phase 12a open-label non-randomized multi-dose study of mirdametinib monotherapy in adults with NF1 and cNF The study will be conducted in two phases

Phase 1 will test the safety of multiple dose regimens of mirdametinib in order to identify a recommended phase 2 doses for phase 2a The phase 1 portion will enroll participants in dose regimens 1 to 3 concurrently Enrollment of participants to dose regimen 4 will be conducted only if no dose limiting toxicities DLT occurred in any of the three previous regimens within at least the first three cycles The study will continue until one of the following stopping conditions is met

The RP2Ds have been identified with sufficient accuracy The dose regimens selected as the RP2D have been fully enrolled with at least 3 cycles of treatment completed for all participants
All dose regimens are deemed to have unacceptable safety

Phase 2a of the study will test the efficacy and safety of a maximum of two RP2Ds in adults with NF1 and cNF

This study will be considered complete once all participants have ceased study treatment due to death disease progression intolerance withdrawal of consent from the study physician discretion or completed a maximum of 48 cycles of treatment across both phase 1 and phase 2a Each treatment cycle is 28 days

In both Phases of the study participation in the study will comprise three periods screening treatment and post-study safety follow-up to be performed at Johns Hopkins University

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
Secondary IDs
Secondary ID Type Domain Link
J23129 OTHER SKCCC None