Ulixertinib for Cancer

Recruiting at 6 trial locations

Overseen By Rona Yaeger, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Chemotherapy, BRAF inhibitors, MEK inhibitors

Must not be taking: CYP inhibitors, P-glycoprotein inhibitors

Disqualifiers: Uncontrolled conditions, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

38 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that you stop taking any histiocytic neoplasm-directed therapy (like chemotherapy or targeted therapy) at least 28 days before starting ulixertinib. Also, you cannot take certain medications that affect specific liver enzymes (CYP1A2, CYP2D6, CYP3A4) or p-glycoprotein inhibitors during the trial.

Research Team

Eli Diamond, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My liver functions are within the required range.

I am at least 18 years old, or at least 12 years old after certain safety checks.

My diagnosis of a histiocytic disorder is confirmed by lab tests and imaging.

Exclusion Criteria

I do not have any serious active infections.

I am not taking drugs that affect liver enzymes.

I do not have any severe or uncontrolled health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ulixertinib

Trial Overview 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.

Participant Groups

Group I: No Mitogen-activated protein kinase (MAPK) pathway mutation identified (exploratory cohort) Experimental Treatment 1 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 Treatment 1 Intervention

Patients in this study will receive ulixertinib, starting at 300 mg twice daily, for every 28-day cycle.

Ulixertinib is already approved in United States for the following indications:

Approved in United States as Ulixertinib for:

• None (investigational)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

BioMed Valley Discoveries, Inc

Industry Sponsor

Trials

19

Recruited

650+