Ulixertinib for Cancer

Recruiting in Palo Alto (17 mi)

+114 other locations

Overseen byKieuhoa T Vo

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with solid tumors that have spread to other places in the body (advanced), non-Hodgkin lymphoma, or histiocytic disorders that have a genetic alteration (mutation) in a signaling pathway called MAPK. A signaling pathway consists of a group of molecules in a cell that control one or more cell functions. Genes in the MAPK pathway are frequently mutated in many types of cancers. Ulixertinib may stop the growth of cancer cells that have mutations in the MAPK pathway.

Research Team

Kieuhoa T Vo

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have MAPK pathway mutations. Participants must be able to swallow capsules and have a body surface area of at least 0.54 m^2. They should not have received prior ERK inhibitors and must meet certain blood count criteria without recent transfusions.

Inclusion Criteria

My platelet count is healthy and I haven't needed a transfusion in the last week.

I am enrolled in APEC1621SC and assigned to APEC1621J due to a specific mutation.

All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines

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Exclusion Criteria

You are currently taking other medications for cancer.

I have been on a stable or decreasing dose of corticosteroids for at least 7 days.

I do not have any infections that are currently uncontrolled.

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Treatment Details

Interventions

Ulixertinib (MAPK Pathway Inhibitor)

Trial OverviewThe study tests the effectiveness of Ulixertinib in treating cancers with specific genetic changes in the MAPK pathway. It's for those whose cancer has spread or can't be removed by surgery, focusing on how well this drug stops cancer growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (ulixertinib)Experimental Treatment2 Interventions

Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.