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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

September 14, 2021

Primary Completion Date

October 26, 2023

Study Completion Date

October 26, 2023

Conditions
Breast CancerBreast Cancer Stage IVHER2-negative Breast CancerSolid CarcinomaMEK1 Gene MutationMEK2 Gene MutationMetastatic Breast Cancer
Interventions
DRUG

Mirdametinib

Dose Level -2INT: 2mg PO BID, 3 weeks on/1 week off Dose Level -2: 2mg PO BID given continuously Dose Level -1INT: 3mg PO BID, 3 weeks on/1 week off Dose Level -1: 3mg PO BID given continuously Dose Level 1: 4mg PO BID given continuously Dose Level 2: 6mg PO BID given continuously Dose Level 3: 8mg PO BID given continuously

DRUG

Fulvestrant

"The starting dose of mirdametinib in combination with fulvestrant in each Dose Level will be as follows:~* Dose Level 1: mirdametinib 4 mg BID PO + fulvestrant~* (Only to be triggered pending DLTs on higher Dose Levels as described below)~ * Dose Level -2: mirdametinib 2 mg BID PO continuous + fulvestrant, and Dose Level -2INT: mirdametinib 2 mg BID PO on 3 weeks on, 1 week off + fulvestrant"

Trial Locations (4)

10065

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

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11725

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack

07748

Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT05054374 - A Study of Mirdametinib on Its Own or in Combination With Fulvestrant in People With Solid Tumor Cancer | Biotech Hunter | Biotech Hunter