Erdafitinib for Castration-Resistant Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Paul Corn

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of erdafitinib in treating patients with prostate cancer that grows and continues to spread despite the surgical removal of the testes or drugs to block androgen production (castration-resistant). Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erdafitinib may help control disease in patients with castration-resistant prostate cancer. In addition, studying samples of blood, tissue, plasma, and bone marrow from patients with castration-resistant prostate cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Eligibility Criteria

Men aged 18+ with castration-resistant prostate cancer and bone metastases are eligible. They must have had prior treatments like hormone therapy or chemotherapy, but not recent major surgery or radiation. Participants need to maintain low testosterone levels, have adequate organ function, be able to swallow pills, and agree to use contraception.

Inclusion Criteria

You have a sufficient amount of a type of white blood cell called neutrophils.

Your AST or ALT levels in your blood are within a certain range.

Your bilirubin levels in the blood are within a certain range, unless you have a condition called Gilbert's disease.

Exclusion Criteria

I haven't been part of any drug trials or received experimental treatments in the last 30 days.

You have a current hepatitis B or C infection.

I am still experiencing side effects from previous cancer treatments.

Participant Groups

The trial is testing Erdafitinib's effectiveness in treating advanced prostate cancer that resists standard treatment. It involves taking the drug orally and monitoring its impact on tumor growth by blocking enzymes needed for cell growth.

Group I: Treatment (erdafitinib, biospecimen collection) Experimental Treatment 3 Interventions

Patients receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may also undergo collection of blood and bone marrow via biopsy and aspirates.

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

🇺🇸 Approved in United States as Balversa for:

• Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

🇪🇺 Approved in European Union as Balversa for:

• Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References