Actively Recruiting
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-13
54
Participants Needed
7
Research Sites
182 weeks
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
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
Official Title
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of unresectable, recurrent, or metastatic dedifferentiated liposarcoma
- Measurable disease as defined by RECIST 1.1 criteria
- Evidence of disease progression within 6 months for Phase II participants
- ECOG performance status of 2 or less
- Adequate organ and marrow function including neutrophils, hemoglobin, platelets, liver enzymes, creatinine clearance, coagulation, cardiac function, blood glucose, calcium, phosphate, and eye pressure
- Women of childbearing potential must agree to use effective contraception during the trial and for six months after last dose
- Male patients or their partners must use contraception during treatment and for three months after
- Ability to understand and sign informed consent
- Ability to swallow tablets or capsules
- Patients with treated and stable brain metastasis for at least 3 months are eligible
You will not qualify if you...
- Unresolved adverse events from prior therapies greater than grade 1 except alopecia and stable neuropathy
- Receiving other investigational agents
- Prior treatment with selective CDK4 or MEK inhibitors (Phase II only)
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, arrhythmias, psychiatric illness limiting compliance, or active lung disease
- NYHA class III or IV congestive heart failure within 6 months
- Significant cardiac disease history including recent myocardial infarction or severe angina
- Pregnant or breastfeeding women
- Prolonged QTcF over 470ms
- Chronic kidney disease stage greater than 3 or creatinine clearance below 60 mL/min
- History or current interstitial lung disease
- Eye diseases such as glaucoma or risk factors for retinal vein occlusion
- Neuromuscular disorders linked to elevated muscle enzymes
- Recent radiation or major surgery within 2 weeks prior to treatment
- Use of systemic or ocular glucocorticoids within 14 days before treatment
- Known severe hypersensitivity to study drugs or related compounds
- Previous severe toxicity from CDK4/6, MEK, or ERK inhibitors
- Active malignancies within 12 months
- Disorders affecting swallowing or drug absorption
- Use of medications strongly affecting CYP3A or UGT enzymes
- Unstable or severe neuropathy or neurological symptoms within 4 weeks before treatment
AI-Screening
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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
CONTACT
W
William Tap, MD
CONTACT
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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