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Hormone Therapy

Mirdametinib for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Ezra Rosen, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days from first day of treatment

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a drug called mirdametinib is safe for people with advanced solid tumor cancer.

Eligible Conditions

Breast Cancer
MEK1 Gene Mutation
Cancer
MEK2 Gene Mutation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days from first day of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days from first day of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days from first day of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Treatment/DLT Evaluable Population

Side effects data

From 2023 Phase 1 & 2 trial • 6 Patients • NCT05054374

33%

CPK increased

33%

Lymphocyte count decreased

17%

Alkaline phosphatase increased

17%

Aspartate aminotransferase increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1, Part 1 - Mirdametinib in Combination With Fulvestrant

Arm 1, Part 2 - Mirdametinib in Combination With Fulvestrant

Arm 2, Part 1 - Mirdametinib as Single Agent

Arm 2, Part 2 - Mirdametinib as Single Agent

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm 2, Part 2 - mirdametinib as single agentExperimental Treatment1 Intervention

Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 2: dose expansion cohorts

Group II: Arm 2, Part 1 - mirdametinib as single agentExperimental Treatment1 Intervention

Adult patients with advanced solid cancers driven by the alteration of the MAPK pathway Part 1: mirdametinib dose escalation to MTD or RP2D according to the 3+3 design

Group III: Arm 1, Part 2 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions

Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 2: dose expansion cohorts where the mirdametinib RP2D will be administered in combination with the standard recommended dose of fulvestrant

Group IV: Arm 1, Part 1 - mirdametinib in combination with fulvestrantExperimental Treatment2 Interventions

Postmenopausal patients with estrogen receptor positive metastatic breast cancer harboring NF1 loss of function or another alteration of the MAPK pathway. Part 1: safety run-in (confirmation of the RP2D for mirdametinib in combination with the standard recommended dose of fulvestrant). This part may include the mirdametinib dose de-escalation according to the 3+3 design if necessary

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirdametinib

2021

Completed Phase 2

~10

Fulvestrant

2011

Completed Phase 3

~3510