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Mirdametinib

Generic Name
Mirdametinib
Drug Type
Small Molecule
Chemical Formula
C16H14F3IN2O4
CAS Number
391210-10-9
Unique Ingredient Identifier
86K0J5AK6M
Background

PD-0325901 has been used in trials studying the treatment and basic science of Melanoma, Solid Tumour, Solid Tumors, Advanced Cancer, and Breast Neoplasms, among others.

Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma

Phase 1
Not yet recruiting
Conditions
Multiple Myeloma
Relapsed and/or Refractory Multiple Myeloma (RRMM)
Interventions
First Posted Date
2025-03-14
Last Posted Date
2025-05-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
54
Registration Number
NCT06876142
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma

Phase 1
Recruiting
Conditions
Well Differentiated Liposarcoma
Dedifferentiated Liposarcoma
Liposarcoma
Myxoid Liposarcoma
Round Cell Liposarcoma
Myxoid Pleomorphic Liposarcoma
Pleomorphic Liposarcoma
Unresectable Liposarcoma
Unresectable Dedifferentiated Liposarcoma
Interventions
First Posted Date
2025-02-25
Last Posted Date
2025-05-01
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
54
Registration Number
NCT06843967
Locations
🇺🇸

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States

🇺🇸

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]

Early Phase 1
Recruiting
Conditions
Primary Malignant Peripheral Nerve Sheath Tumors
Interventions
First Posted Date
2024-11-18
Last Posted Date
2025-01-14
Lead Sponsor
University of Minnesota
Target Recruit Count
8
Registration Number
NCT06693284
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK

Phase 1
Not yet recruiting
Conditions
Pediatric Low-grade Glioma
Interventions
First Posted Date
2024-10-30
Last Posted Date
2025-02-11
Lead Sponsor
C17 Council
Target Recruit Count
50
Registration Number
NCT06666348

Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).

Phase 1
Recruiting
Conditions
NF1
Cutaneous Neurofibroma
Monotherapy
Interventions
First Posted Date
2023-12-06
Last Posted Date
2025-04-23
Lead Sponsor
Johns Hopkins University
Target Recruit Count
24
Registration Number
NCT06159166
Locations
🇺🇸

Johns Hopkins Hospital, Baltimore, Maryland, United States

Mirdametinib in Histiocytic Disorders

Phase 2
Recruiting
Conditions
Rosai-Dorfman Disease (RDD)
Histiocytic Disorders
Langerhans Cell Histiocytosis (LCH)
Juvenile Xanthogranuloma (JXG)
Interventions
First Posted Date
2023-12-01
Last Posted Date
2025-04-25
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
40
Registration Number
NCT06153173
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Phase 2
Recruiting
Conditions
Venous Malformation
Slow-Flow Vascular Malformation
Fast-Flow Vascular Malformation
Arteriovenous Malformations
PIK3CA-related Overgrowth Spectrum
Lymphatic Malformation, Low Flow
Lymphatic Malformation
Vascular Anomaly
KRAS G12D
Vascular Malformations
Interventions
First Posted Date
2023-08-09
Last Posted Date
2025-04-13
Lead Sponsor
Murdoch Childrens Research Institute
Target Recruit Count
50
Registration Number
NCT05983159
Locations
🇦🇺

Peter MacCallum Cancer Centre, Parkville, Victoria, Australia

🇦🇺

The Royal Children's Hospital, Parkville, Victoria, Australia

Mirdametinib + BGB-3245 in Advanced Solid Tumors

Phase 1
Terminated
Conditions
Advanced Solid Tumor
Interventions
First Posted Date
2022-10-14
Last Posted Date
2025-02-17
Lead Sponsor
SpringWorks Therapeutics, Inc.
Target Recruit Count
23
Registration Number
NCT05580770
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Yale-New Haven Hospital-Yale Cancer Center, New Haven, Connecticut, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 5 locations

A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer

Phase 1
Completed
Conditions
Breast Cancer
HER2-negative Breast Cancer
MEK1 Gene Mutation
Metastatic Breast Cancer
Breast Cancer Stage IV
MEK2 Gene Mutation
Solid Carcinoma
Interventions
First Posted Date
2021-09-23
Last Posted Date
2024-07-09
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
6
Registration Number
NCT05054374
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

and more 1 locations
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