Changeflow GovPing Healthcare & Life Sciences Phase 1 Mirdametinib Trial for CNS Tumors
Routine Notice Added Final

Phase 1 Mirdametinib Trial for CNS Tumors

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Summary

NIH registered Phase 1 trial NCT07539441 to evaluate mirdametinib as a treatment for central nervous system tumors, specifically glioma and neurohistiocytosis. The study is listed on ClinicalTrials.gov as a Phase 1 safety and efficacy assessment. No compliance obligations or deadlines are associated with this registration notice.

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What changed

NIH added a new Phase 1 clinical trial registration for mirdametinib (a targeted therapy) in patients with central nervous system tumors. The trial covers two conditions: glioma and neurohistiocytosis. No regulatory obligations arise from this registration notice itself.\n\nFor pharmaceutical sponsors and clinical investigators, this registration demonstrates continued NIH oversight of oncology trial activity. Trial sponsors conducting applicable clinical trials should ensure compliance with ClinicalTrials.gov registration and results reporting requirements under FDAAA 801.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

A Study of Mirdametinib in People With Central Nervous System Tumors

Phase 1 NCT07539441 Kind: PHASE1 Apr 20, 2026

Abstract

The purpose of this study to find out whether mirdametinib is a safe and effective treatment for Central Nervous System/CNS tumors (glioma and neurohistiocytosis).

Conditions: Central Nervous System Tumors, Glioma

Interventions: Mirdametinib

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07539441

Who this affects

Applies to
Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing 6211 Healthcare Providers
Activity scope
Clinical trial registration Drug development Oncology research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Pharmaceuticals Public Health

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