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Tyrosine Kinase Inhibitor

Erdafitinib for Castration-Resistant Prostate Cancer

Phase 2

Waitlist Available

Led By Paul Corn

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented evidence of progressive disease as defined by PSA progression, new or increasing non-bone disease, or positive bone scan with 2 or more new lesions

Prior treatment with a second-generation AR-targeting agent, immunotherapies, or bone targeting therapies

Must not have

Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 30 days prior to randomization

Eye conditions likely to increase the risk of eye toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effect of erdafitinib in treating patients with prostate cancer that has continued to grow despite the surgical removal of the testes or drugs to block androgen production.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Erdafitinib may cause side effects such as changes in liver enzyme levels, fatigue, digestive issues like nausea or diarrhea, mouth sores, skin rash or nail changes. Blood tests will monitor potential impacts on kidney function and blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is getting worse, shown by tests.

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I have previously been treated with specific prostate cancer or bone therapies.

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My kidneys are functioning well enough to clear waste.

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I am 18 years old or older.

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My testosterone levels are low, and I am maintaining it with hormone therapy or have had an orchiectomy.

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I can swallow pills without any difficulty.

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My prostate cancer has spread to my bones.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have eye conditions that could worsen with treatment.

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My wounds heal slowly or poorly.

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I have not had major surgery in the last 4 weeks.

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I have untreated spinal cord compression that causes symptoms.

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My high blood pressure is not well-controlled with medication.

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I haven't had cancer treatment in the last year, nor is my cancer likely to return soon.

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I have a history of heart disease that is not well-controlled.

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I haven't had radiation therapy in the last 2 weeks.

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I have active AIDS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone specific alkaline phosphatase (BAP) modulation

Secondary study objectives

Incidence of adverse events

Overall response rate

Overall survival

+3 more

Other study objectives

Bone Marrow

Change in global messenger ribonucleic acid gene expression in bone marrow biopsy aspirate

Plasma biomarker analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (erdafitinib, biospecimen collection)Experimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Erdafitinib

2017

Completed Phase 2

~150