Ulixertinib in People With Histiocytic Neoplasms

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06411821
Phase
PHASE2
Status
Recruiting

Conditions

  • Histiocytic Neoplasms

Eligibility Criteria

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

Interventions

  • Ulixertinib — DRUG
    300 mg twice daily, for every 28-day cycle.

Study Details

The researchers are doing this study is to find out whether ulixertinib is an effective and safe treatment for people with histiocytic neoplasms.

Key Dates

Start date
May 7, 2024
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mitogen-activated protein kinase (MAPK) pathway mutation (primary cohort)
    Patients in this study will receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle.
  • Experimental: No Mitogen-activated protein kinase (MAPK) pathway mutation identified (exploratory cohort)
    Patients in this study will receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle.

Primary Outcome Measure

overall response rate [ Time Frame: 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Clinic (Data Collection Only)RochesterMinnesota55905
Jithma Abeykoon, MD
507-284-2511
Memorial Sloan Kettering Basking Ridge (Consent Only)Basking RidgeNew Jersey07920
Eli Diamond, MD
212-610-0243
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Eli Diamond, MD
212-610-0243
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Eli Diamond, MD
212-610-0243
Memorial Sloan Kettering Suffolk-Commack (Consent Only)CommackNew York11725
Eli Diamond, MD
212-610-0243
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Eli Diamond, MD
212-610-0243
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Eli Diamond, MD
212-639-7576
Rona Yaeger, MD
646-888-5109
Eli Diamond, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Consent Only)UniondaleNew York11553
Eli Diamond, MD
212-610-0243

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