Study on Mirdametinib and Palbociclib for Treating Liposarcoma

Inclusion Criteria

• Diagnosed with liposarcoma that cannot be removed by surgery, has returned, or has spread to other parts of the body.
• For Phase II, any number of previous treatments is allowed.
• Must have measurable disease and show signs of disease progression.
• Must be 18 years or older.
• Must be in relatively good health with an ECOG performance status of 0, 1, or 2.
• Must have adequate organ and bone marrow function, as shown by specific blood test results.
• Must have normal blood clotting and heart function.
• Must have controlled blood sugar levels.
• Must have normal calcium and phosphate levels.
• Must have normal eye pressure.
• Women of childbearing potential must use effective birth control during the study and for six months after the last dose. Men must use effective birth control during the study and for three months after.
• Must be able to understand and sign a consent form.
• Must be able to swallow pills.
• Patients with treated and stable brain metastases are eligible.

Exclusion Criteria

• Have not recovered from significant side effects of previous treatments, except for hair loss and stable nerve damage.
• Currently taking other experimental drugs.
• For Phase II, have previously been treated with CDK4 or MEK inhibitors.
• Have uncontrolled illnesses, such as active infections, heart failure, or psychiatric conditions that could interfere with the study.
• Have a history of severe heart disease or recent heart attack.
• Pregnant or breastfeeding women.
• Have a prolonged QT interval on an ECG.
• Have severe kidney disease or low creatinine clearance.
• Have a history of lung disease or glaucoma.
• Have a neuromuscular disorder that could cause high CPK levels.
• Have had radiation therapy or major surgery recently.
• Taking steroids or have a known allergy to the study drugs.
• Have had significant side effects from similar drugs in the past.
• Have another active cancer within the last year.
• Have difficulty swallowing pills or absorbing oral medications.
• Taking medications that strongly affect liver enzymes.
• Have severe nerve damage or unstable neurological symptoms.