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NCT06159166 · ClinicalTrials.gov registry record · Phase 1
Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).
A Phase 1 study of NF1 and Cutaneous Neurofibroma, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06159166: Recruiting Phase 1 study of NF1 and Cutaneous Neurofibroma, sponsored by Johns Hopkins University.
NCT06159166 is a Phase 1 study of NF1 and Cutaneous Neurofibroma that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 24 participants, below the 76-participant average among 6 other NF1 trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06159166, a Phase 1 study of NF1 and Cutaneous Neurofibroma, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1/2a, 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.
Primary Outcome
Phase 1 will test the safety and tolerability of multiple dose regimens of mirdametinib, in order to identify the recommended phase 2 dose(s) for phase 2a. The study will continue until one of the stopping conditions is met. * The RP2D(s) have been identified with sufficient accuracy (The dose regimen(s) 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 The study will conti
Conditions Studied
Interventions
- DRUG Mirdametinib
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-02-12 |
| Est. Completion | 2028-11-15 |
| Phase | Phase 1 |
What NCT06159166 shows while recruiting
NCT06159166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 76-participant average among 6 other NF1 trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with NF1 appearing as the primary indexed condition, and to 1 intervention - of which Mirdametinib is the first listed.
NCT06159166 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06159166 about?
NCT06159166 is a clinical study titled "Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).". This is a Phase 1/2a, 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 spe...
What is the current status of trial NCT06159166?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-02-12. Estimated completion is 2028-11-15.
What conditions does trial NCT06159166 study?
This clinical trial studies the following conditions: NF1, Cutaneous Neurofibroma, Monotherapy.
What interventions are being tested in trial NCT06159166?
The interventions under investigation include: Mirdametinib (DRUG).
Who is sponsoring clinical trial NCT06159166?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06159166 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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