Phase 1 / Phase 2: testing Mirdametinib for Well Differentiated Liposarcoma
This study wants 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.
Official registry: https://clinicaltrials.gov/study/NCT06843967 · Memorial Sloan Kettering Cancer Center · enrollment listed as 54
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Mirdametinib, or Palbociclib. The registry lists allocation as randomized. This study wants to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma.
They plan to enroll about 54 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma
Interventions: Mirdametinib, Palbociclib
Primary outcome (registry wording): Maximum tolerated dose (Phase I)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- A diagnosis of unresectable, recurrent, or metastatic DDLPS
- Measurable disease as defined by RECIST 1.1
- 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)
- how well you can do daily activities (ECOG score) ≤ 2
- Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):
Who the registry excludes
- Patients who have not recovered from clinically significant side effects of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline
- Patients receiving any other investigational agents
- Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor
- Patients with a CD4+ count of \> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion
- Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded
- Pregnant women and women who are breast-feeding
- Prolonged QTcF \> 470ms at Screening, irrespective of sex
Public study contact (from the registry)
Olayode Babatunde, MD
zzPDL_MED_Sarcoma_Clinical_Trials@mskcc.org
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
7 listed- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey (recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey (recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey (recruiting)
- Memorial Sloan Kettering Cancer Center Suffolk- Commack (Limited Protocol Activities) — Commack, New York (recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York (recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York (recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York (recruiting)
FAQ about this NCT record
Is NCT06843967 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06843967?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06843967?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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