Actively Recruiting
Phase IbII Study of Mirdametinib Combined With Palbociclib for Advanced Dedifferentiated Liposarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-22
54
Participants Needed
7
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether the combination of mirdametinib and palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. The study focuses on patients with advanced dedifferentiated liposarcoma DDLPS, testing different doses of mirdametinib alongside a fixed dose of palbociclib to identify the best safe dose for further research. The study includes a dose escalation phase Phase I to determine the maximum tolerated dose of mirdametinib combined with palbociclib, followed by a Phase II portion where 30 patients with advanced DDLPS will receive the recommended Phase II dose RP2D of the drug combination. Treatment involves taking oral tablets of both drugs, with dosing schedules designed to find the safest and most effective regimen. Participants will be monitored for up to one year in Phase I to assess the maximum tolerated dose and for at least 18 weeks in Phase II to evaluate progression-free survival rate. Assessments include measuring tumor response by RECIST 1.1 criteria, organ and marrow function tests, cardiac evaluations, blood glucose control, and eye pressure checks. Safety and disease progression will be closely followed during and after treatment.
CONDITIONS
Brief Title
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Research Team
O
Olayode Babatunde, MD
W
William Tap, MD
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