mirdametinib
mirdametinib: developed by 1 company · 10 clinical trials tracked.
mirdametinib evidence translation
What we can confirm
10 tracked trials
What it means
What to watch
Prepared research question
How could mirdametinib → SWTX affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence6 indications · 2 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| SpringWorks Therapeutics, Inc. (SWTX) Treatment of solid tumors harboring MAPK pathway aberrations… | Phase 2 |
Clinical Trials (10)
Individual Patient Compassionate Use of Mirdametinib
Phase 1/2 Trial of Mirdametinib in Patients With MAPK Pathway Mutant Central Nervous System Tumors
Primary endpoint: Best overall neurologic response rate
A Phase 1, Open-Label Study to Assess the Enzyme Inducing Effects of Carbamazepine on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants
Primary endpoint: The geometric mean ratio of mirdametinib plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) of Mirdametinib
A Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function
Primary endpoint: Maximum plasma concentration (Cmax) of mirdametinib
A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma
Primary endpoint: Maximum tolerated dose (Phase I)
A Modular Open Label, Signal Seeking, Phase II Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (TARGET-VM)
Primary endpoint: The number of participants who achieve or exceed a predetermined threshold of improvement in their most significant symptom at 48 weeks based on the Vascular Malformation Patient Specific Outcome Measure (VM-PSOM).
A Phase 1/2a 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).
Primary endpoint: Assess the safety of continuous and three week on-one week off dosing of mirdametinib in adults with NF1 and cutaneous neurofibromas (cNFs).
A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors
Primary endpoint: Incidence of Treatment Emergent Adverse Events
SJ901: Phase 1/2 Evaluation of Single Agent Mirdametinib (PD-0325901), a Brain-Penetrant MEK1/2 Inhibitor, for the Treatment of Children, Adolescents, and Young Adults With Low-Grade Glioma
Primary endpoint: Phase 1: Estimate the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of mirdametinib dosed twice daily on a continuous schedule in pediatric patients with progressive or recurrent low-grade glioma.
A Phase 1b, Open-Label, Dose-escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of a RAF Dimer Inhibitor BGB-283 in Combination With MEK Inhibitor PD-0325901 in Patients With Advanced or Refractory Solid Tumors
Primary endpoint: Adverse Events and Serious Adverse Events
Frequently asked questions
Who is developing mirdametinib?
mirdametinib is being developed by SpringWorks Therapeutics, Inc..
How many clinical trials involve mirdametinib?
BioSniper tracks 10 clinical trials involving mirdametinib.