A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Phase I only: * A diagnosis of unresectable, recurrent, or metastatic DDLPS * Measurable disease as defined by RECIST 1.1 Phase II only: * A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS * Any number of prior lines of therapy * Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration) * Age ≥ 18 years * ECOG performance status ≤ 2 * Ade…