Study on Ulixertinib for People with Histiocytic Neoplasms

Inclusion Criteria

• Have a confirmed diagnosis of histiocytic neoplasm, which may be supported by imaging or genetic tests.
• Have a mutation in specific genes related to the MAPK pathway, such as BRAF or KRAS, identified through tumor or blood tests.
• Have measurable disease as confirmed by a radiologist.
• Be 18 years or older before certain safety checks, or 12 years and older after these checks.
• Have a type of histiocytic neoplasm that has not responded to other treatments, affects multiple systems, or causes significant organ problems.
• Have tried previous treatments like chemotherapy or BRAF/MEK inhibitors and still have active disease or cannot tolerate these treatments.
• Be in good general health with a performance status score of 0 to 2 for adults or 50-100 for younger patients.
• Have good kidney function based on specific medical tests.
• Have good liver function with certain blood test results.
• Have good bone marrow function with adequate blood cell counts.
• Have good heart function with specific test results.
• Agree to use effective birth control during and for three months after the study if of childbearing potential.
• Be willing and able to participate in the study and follow all requirements.
• Have no other cancers that could interfere with the study, unless approved by the study doctor.

Exclusion Criteria

• Have uncontrolled or severe medical conditions.
• Have received any treatment for histiocytic neoplasm within 28 days before starting ulixertinib.
• Have a type of histiocytic neoplasm that should only be monitored or treated locally according to guidelines.
• Have had major surgery within four weeks before starting ulixertinib.
• Be pregnant or breastfeeding.
• Have serious active infections unless fever-free for at least 48 hours.
• Have a history or risk of certain eye conditions.
• Be taking medications that strongly affect certain liver enzymes.
• Be unable to swallow pills or have had certain stomach surgeries.
• Be participating in another clinical trial or taking investigational drugs within 28 days before starting this study.