Actively Recruiting
A Phase Ib/II Study of Mirdametinib in Combination With Palbociclib in Patients With 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
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
S
SpringWorks Therapeutics, Inc.
Collaborating Sponsor
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of unresectable, recurrent, or metastatic dedifferentiated liposarcoma (DDLPS)
- Measurable disease as defined by RECIST 1.1 criteria
- Age 18 years or older
- ECOG performance status 2 or less
- Adequate organ and marrow function, including neutrophil count, hemoglobin, platelets, bilirubin, liver enzymes, and creatinine clearance
- Adequate coagulation function with stable INR and PTT
- Adequate cardiac function with blood pressure under specified limits, LVEF 50% or higher, and normal ECG
- Adequate blood sugar control
- Normal serum calcium and phosphate levels
- Intraocular pressure 21 mmHg or less in both eyes
- Women of child-bearing potential must use effective contraception during and for six months after the trial; men or their partners must use contraception during and for three months after treatment
- Ability to understand and sign informed consent
- Ability to swallow tablets or capsules
- Patients with treated, stable brain metastasis for at least 3 months are eligible
You will not qualify if you...
- Unresolved adverse events from prior therapy greater than Grade 1 (except alopecia and stable neuropathy up to Grade 2)
- Receiving other investigational agents
- Prior treatment with selective CDK4 or MEK inhibitors (Phase II only)
- Uncontrolled illness including active infections, symptomatic heart failure, unstable angina, uncontrolled arrhythmias, psychiatric/social issues limiting compliance, interstitial lung disease, or active infection needing systemic therapy
- NYHA Class III or IV heart failure within 6 months
- Significant cardiac disease or events within 6 months before study
- Pregnant or breastfeeding women
- Prolonged QTcF interval greater than 470 ms
- Chronic kidney disease stage above 3 or creatinine clearance below 60 mL/min
- History or current interstitial lung disease
- Eye diseases like glaucoma or retinal disorders that increase risk
- Neuromuscular disorders with elevated CPK
- Radiation therapy or major surgery within 2 weeks before treatment without full recovery
- Use of systemic or ocular glucocorticoids within 14 days before treatment (except physiological doses for endocrine deficiencies)
- Severe hypersensitivity to study drugs or related compounds
- History of severe toxicity to CDK4/6, MEK, or ERK inhibitors
- Active malignancies within 12 months
- Conditions affecting swallowing or drug absorption
- Use of medications strongly affecting CYP3A or UGT enzymes
- Non-tolerable Grade 2 or higher neuropathy or unstable neurological symptoms within 4 weeks before treatment start, interfering with daily activities or lasting 7 days or more
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year in Phase I; 18 weeks in Phase II
Participants receive mirdametinib in combination with palbociclib as part of the study treatment for advanced dedifferentiated liposarcoma.
Visits occur as scheduled during treatment to monitor safety and response
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
O
Olayode Babatunde, MD
W
William Tap, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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