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 — DRUG300 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
- Eli Diamond, MD212-610-0243
- Rona Yaeger, MD646-888-5109
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic (Data Collection Only) | Rochester | Minnesota | 55905 | |
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | New Jersey | 07920 | Eli Diamond, MD 212-610-0243 |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey | 07748 | Eli Diamond, MD 212-610-0243 |
| Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey | 07645 | Eli Diamond, MD 212-610-0243 |
| Memorial Sloan Kettering Suffolk-Commack (Consent Only) | Commack | New York | 11725 | Eli Diamond, MD 212-610-0243 |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York | 10604 | Eli Diamond, MD 212-610-0243 |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York | 10065 | Eli Diamond, MD 212-639-7576 Rona Yaeger, MD 646-888-5109 Eli Diamond, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Nassau (Consent Only) | Uniondale | New York | 11553 | Eli Diamond, MD 212-610-0243 |
Find similar trials in Rochester, MN
By research site
Mayo Clinic (Data Collection Only)· Rochester, MNMemorial Sloan Kettering Basking Ridge (Consent Only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Consent Only)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Consent Only)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NY
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