Selumetinib for Cancer

Recruiting at 115 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Corticosteroids, Investigational drugs, Anti-cancer agents, others

Disqualifiers: Pregnancy, Uncontrolled infection, Ophthalmologic conditions, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II Pediatric MATCH trial studies how well selumetinib sulfate works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib sulfate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Research Team

Carl E Allen

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 and are not responding to treatment. Participants must be able to swallow capsules, have a body surface area >= 0.5 m^2, and meet specific health criteria including organ function and blood counts. Pregnant women or those on certain medications cannot join.

Inclusion Criteria

I have recovered from side effects of my previous cancer treatments.

My stem cell treatment followed the required time guidelines.

My cancer has a specific BRAF V600 mutation.

Exclusion Criteria

Pregnant or breast-feeding women

I am currently taking other medications.

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 selumetinib sulfate 25 mg/m2/dose orally twice daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Treatment Details

Interventions

• Selumetinib Sulfate

Trial Overview The study tests Selumetinib Sulfate's effectiveness in treating relapsed or refractory cancers with MAPK mutations. It's a phase II trial aiming to see if this drug can halt cancer cell growth by inhibiting necessary enzymes.

Participant Groups

Group I: Treatment (selumetinib) Experimental Treatment 3 Interventions

Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Selumetinib Sulfate is already approved in United States, European Union for the following indications:

Approved in United States as Koselugo for:

• Neurofibromatosis type 1

Approved in European Union as Koselugo for:

• Neurofibromatosis type 1

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+