NCT06843967 · Memorial Sloan Kettering Cancer Center
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
What this study 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.
View original scientific description
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.
Interventions
DRUG
Mirdametinib
Mirdametinib (PD-0325901) is a highly selective non-ATP-competitive inhibitor of MEK1 and MEK2. It significantly inhibits the phosphorylation of the MAP kinases ERK1 and ERK2, leading to impaired tumor cell growth in vitro and in vivo in a broad spectrum of human tumors
DRUG
Palbociclib
Palbociclib (IBRANCE®) is a kinase inhibitor FDA approved for the following indications: treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men or fulvestrant in patients with disease progression following endocrine therapy.
Primary outcome measures
Maximum tolerated dose (Phase I)
Time frame: Up to 1 year
To determine the recommended phase 2 dose (RP2D) of mirdametinib plus palbociclib in patients with DDLPS
Progression free survival rate
Time frame: 18 weeks
Phase II: To determine the progression-free survival rate at 18 weeks by RECIST 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 U
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Collaborators
SpringWorks Therapeutics, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations