A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma (NCT06843967) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
United States54 participantsStarted 2025-02-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
* Absolute neutrophil count ≥ 1.5 x 109/L
* Hemoglobin ≥ 9.0 g/dL
* Platelets ≥ 100 x 109/L
* Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN, except patients with Gilbert's disease (≤3x ULN)
* AST (SGOT) /ALT (SGPT) ≤ 1.5 x institutional ULN
* Creatinine Clearance ≥ 60 mL/min (calculated by Cockcroft-Gault method)
* Adequate coagulation function, as determined by:
* International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \> 1.5 × ULN is permitted but the dose must be stable for at least 2 weeks before the start of the study treatments.
* PTT ≤ 1.5 × ULN.
* Adequate cardiac function, as determined by:
* Systolic blood pressure \< 160 mmHg and diastolic blood pr…