RecruitingPhase 1Phase 2NCT06843967

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

54 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

Liposarcoma Dedifferentiated Liposarcoma Pleomorphic Liposarcoma Myxoid Liposarcoma Unresectable Liposarcoma Unresectable Dedifferentiated Liposarcoma Well Differentiated Liposarcoma Round Cell Liposarcoma Myxoid Pleomorphic Liposarcoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — mirdametinib and palbociclib — in people with a type of fat tissue cancer called dedifferentiated liposarcoma (DDLPS) that cannot be surgically removed or has come back after treatment. **You may be eligible if...** - You have been diagnosed with unresectable, recurrent, or metastatic dedifferentiated liposarcoma (DDLPS) - Your cancer is measurable on imaging scans - You have had prior treatment (any number of prior lines is acceptable for Phase II) **You may NOT be eligible if...** - You have significant heart problems that affect heart rhythm - You have uncontrolled infections or serious other illnesses - You are pregnant or breastfeeding - You have received certain prior therapies that conflict with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirdametinib

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

DRUGPalbociclib

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.

Locations(7)

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

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06843967

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