Trials / Recruiting

RecruitingNCT06843967

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

A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 54 (estimated)

Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.

Conditions

Interventions

Type	Name	Description
DRUG	Mirdametinib	Mirdametinib (PD-0325901) is a highly selective non-ATP-competitive inhibitor of MEK1 and MEK2. It significantly inhibits the phosphorylation of the MAP kinases ERK1 and ERK2, leading to impaired tumor cell growth in vitro and in vivo in a broad spectrum of human tumors
DRUG	Palbociclib	Palbociclib (IBRANCE®) is a kinase inhibitor FDA approved for the following indications: treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men or fulvestrant in patients with disease progression following endocrine therapy.

Timeline

Start date: 2025-02-19
Primary completion: 2028-08-19
Completion: 2028-08-19
First posted: 2025-02-25
Last updated: 2026-03-13

Locations

7 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06843967. Inclusion in this directory is not an endorsement.