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MEK Inhibitor

Ulixertinib for Cancer

Phase 2
Recruiting
Led By Eli Diamond, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed histiocytic neoplasm or histologic findings consistent with histiocytic neoplasm with confirmatory radiologic or molecular findings
Identified mutation in MAPK pathway genes, including but not limited to ARAF, BRAF, RAF1, NRAS, KRAS, MAP2K1, MAP2K2, and NF1
Must not have
Uncontrolled or severe intercurrent medical condition
History or current evidence of risk of retinal vein occlusion or central serous retinopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial is being conducted to determine if ulixertinib is a safe and effective treatment for individuals with histiocytic neoplasms."

Who is the study for?
Adults with histiocytic neoplasms, a type of tumor, can join this trial. They must have tried other treatments without success or be unlikely to benefit from conventional therapies. Participants need proper liver and kidney function, no severe infections or medical conditions, and cannot be pregnant. A mutation in certain genes is required.
What is being tested?
The study tests ulixertinib's effectiveness and safety for treating histiocytic neoplasms. It involves people who've had prior treatments but still show disease progression or intolerance to those treatments.
What are the potential side effects?
Potential side effects are not detailed here but may include typical reactions to cancer medications such as fatigue, digestive issues, skin reactions, blood disorders, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis of a histiocytic disorder is confirmed by lab tests and imaging.
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My cancer has a mutation in a gene related to cell growth.
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I am at least 18 years old, or at least 12 years old after certain safety checks.
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I am 16 or older with good physical function or aged 12-15 with moderate to excellent activity levels.
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My kidney function is within the required range.
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My liver functions are within the required range.
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My blood tests show normal levels of hemoglobin, platelets, and neutrophils.
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My heart is strong and beats normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe or uncontrolled health conditions.
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I have a history or risk of eye vein blockage or swelling.
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I cannot swallow pills.
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I am not taking drugs that affect liver enzymes.
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My condition requires only observation or initial local treatment.
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I have not had major surgery within the last 4 weeks.
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I do not have any serious active infections.
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I haven't taken any experimental drugs recently and any side effects I had are mild now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
overall response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: No Mitogen-activated protein kinase (MAPK) pathway mutation identified (exploratory cohort)Experimental Treatment1 Intervention
Patients in this study will receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle.
Group II: Mitogen-activated protein kinase (MAPK) pathway mutation (primary cohort)Experimental Treatment1 Intervention
Patients in this study will receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ulixertinib
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,972 Previous Clinical Trials
597,690 Total Patients Enrolled
1 Trials studying Histiocytic Neoplasms
30 Patients Enrolled for Histiocytic Neoplasms
BioMed Valley Discoveries, IncIndustry Sponsor
17 Previous Clinical Trials
571 Total Patients Enrolled
Eli Diamond, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
875 Total Patients Enrolled
~25 spots leftby May 2027
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