Erdafitinib for Cancer

Recruiting at 123 trial locations

Overseen by Alice Lee

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

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Research Team

Alice Lee

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children and young adults aged 12 months to 21 years with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have FGFR mutations. Participants must be able to swallow tablets, have not been treated with erdafitinib before, and meet specific health criteria like normal bilirubin levels and kidney function.

Inclusion Criteria

I have never taken erdafitinib or similar FGFR inhibitor drugs.

My bilirubin levels are within the normal range for my age.

Your heart's QTc interval is less than or equal to 480 milliseconds.

Exclusion Criteria

Investigational drugs: patients who are currently receiving another investigational drug are not eligible

I am not pregnant or breastfeeding, and if capable of having children, I agree to use birth control during and for 3 months after the study.

I have a history of serious heart rhythm problems or specific heart muscle conditions.

Treatment Details

Interventions

• Erdafitinib (Tyrosine Kinase Inhibitor)

Trial Overview The study tests the effectiveness of erdafitinib in patients whose cancer has returned or is resistant to treatment. It aims to see if this drug can stop cancer growth by blocking enzymes needed for cell growth. The trial includes imaging tests like X-rays and MRIs as well as biospecimen collection.

Participant Groups

Group I: Treatment (erdafitinib) Experimental Treatment 11 Interventions

Patients receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+