Ulixertinib for Cancer

Recruiting at 114 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 drugs, CYP1A2 drugs

Disqualifiers: Pregnancy, Uncontrolled infection, 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: 28

Duration: Up to 2 years

20 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking certain medications, such as other anti-cancer agents, investigational drugs, and specific drugs that affect liver enzymes (CYP3A4, CYP1A2, and CYP2D6) at least 14 days before joining. If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before enrolling.

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ulixertinib orally twice daily. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity

Up to 2 years

Monthly visits for each 28-day cycle

Pharmacokinetics Assessment

Pre-dose and post-dose pharmacokinetics assessments on cycle 1, day 1; and pre-dose on cycle 1, day 2, and cycle 1, day 15

1 month

Multiple visits during the first cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• Ulixertinib

Trial Overview The 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

Group I: Treatment (ulixertinib) Experimental Treatment 2 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.

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?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+