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

NCT06843967 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-22

No results posted yet for this study

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

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Olayode Babatunde, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2028-08-19
Completion
2028-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843967 on ClinicalTrials.gov