A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06843967
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Dedifferentiated Liposarcoma
  • Liposarcoma
  • Myxoid Liposarcoma
  • Myxoid Pleomorphic Liposarcoma
  • Pleomorphic Liposarcoma
  • Round Cell Liposarcoma
  • Unresectable Dedifferentiated Liposarcoma
  • Unresectable Liposarcoma
  • Well Differentiated Liposarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib — DRUG
    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
  • Palbociclib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 19, 2025
Status verified
May 2026
Primary completion
Aug 19, 2028
Completion
Aug 19, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I
    Dose escalation phase
  • Experimental: Phase II
    During the phase II portion, 30 patients with advanced DDLPS will be enrolled. All patients in the phase II study will receive the RP2D of mirdametinib plus palbociclib.

Primary Outcome Measure

Maximum tolerated dose (Phase I) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Olayode Babatunde, MD
[email protected]
646-888-4363
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Olayode Babatunde, MD
646-888-4363
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Olayode Babatunde, MD
646-888-4363
Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)CommackNew York11725
Olayode Babatunde, MD
646-888-4363
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Olayode Babatunde, MD
646-888-4363
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Olayode Babatunde, MD
[email protected]
646-888-4363
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Olayode Babatunde, MD
646-888-4363

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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