Elimusertib for Solid Cancers

Recruiting at 28 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: CYP3A4 drugs

Disqualifiers: Pregnancy, Active CNS metastasis, Infection, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 months

31 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on other investigational drugs, anti-cancer agents, or certain medications like cyclosporine and tacrolimus. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What is the purpose of this trial?

This trial tests elimusertib, a pill that blocks enzymes needed for cancer cell growth, in children and young adults with difficult-to-treat cancers. The drug aims to stop cancer cells from repairing and growing.

Research Team

Michael V Ortiz

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Eligibility Criteria

This trial is for young patients (up to 30 years old) with solid tumors or lymphoma that have returned or are treatment-resistant. They must be able to swallow pills, not currently on other cancer treatments or strong CYP3A4 drugs, and can't have active brain metastases or uncontrolled infections.

Inclusion Criteria

I have a solid tumor or lymphoma diagnosis, not originating in the brain.

My cancer has come back or didn't respond to treatment, and was confirmed by a biopsy.

I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

Patients currently receiving another investigational drug

Patients currently receiving other anti-cancer agents

Patients who may not be able to comply with the safety monitoring requirements of the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elimusertib orally twice daily on days 1-3, 8-10, 15-17, and 22-24 of each cycle. Treatment repeats every 28 days for 26 cycles in the absence of disease progression or unacceptable toxicity.

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Every 3 months for 12 months, every 6 months for 24 months, then annually

Treatment Details

Interventions

• Elimusertib

Trial Overview The trial is testing Elimusertib's safety and optimal dosage in treating relapsed/refractory solid tumors. It aims to see if it can halt tumor growth by blocking enzymes needed for cell proliferation.

Participant Groups

Group I: Treatment (elimusertib) Experimental Treatment 1 Intervention

Patients receive elimusertib PO BID on days 1-3, 8-10, 15-17, and 22-24 of each cycle. Treatment repeats every 28 days for 26 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+