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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone specific alkaline phosphatase (BAP) modulation
Secondary outcome measures
Incidence of adverse events
Overall response rate
Overall survival
+3 moreOther outcome measures
Bone Marrow
Change in global messenger ribonucleic acid gene expression in bone marrow biopsy aspirate
Plasma biomarker analysis
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 2
~1730
Erdafitinib
2017
Completed Phase 2
~150
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,205 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
Paul CornPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
230 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a sufficient amount of a type of white blood cell called neutrophils.I haven't been part of any drug trials or received experimental treatments in the last 30 days.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.Willingness to provide tissue and blood samples for additional research.You have a current hepatitis B or C infection.I am still experiencing side effects from previous cancer treatments.My cancer is getting worse, shown by tests.I have eye conditions that could worsen with treatment.My wounds heal slowly or poorly.I have not had major surgery in the last 4 weeks.I have untreated spinal cord compression that causes symptoms.I have previously been treated with specific prostate cancer or bone therapies.My high blood pressure is not well-controlled with medication.My kidneys are functioning well enough to clear waste.Your platelet count is at least 75,000 per microliter of blood.I am a man who will use two forms of birth control and not donate sperm until 3 months after my last treatment dose.I haven't had cancer treatment in the last year, nor is my cancer likely to return soon.I have had a blood clot in my lungs or other veins in the last 2 months.I have a history of heart disease that is not well-controlled.I haven't had radiation therapy in the last 2 weeks.I am 18 years old or older.My testosterone levels are low, and I am maintaining it with hormone therapy or have had an orchiectomy.I can swallow pills without any difficulty.I may or may not have received chemotherapy before.Your blood potassium level is higher than the normal range set by the hospital.Your hemoglobin level needs to be 8.0 grams per deciliter or higher.My prostate cancer has spread to my bones.Your blood magnesium level is higher than the normal range.I can take care of myself but might not be able to do heavy physical work.Your blood albumin level is at least 3.0 grams per deciliter.I have active AIDS.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (erdafitinib, biospecimen collection)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other clinical trials have there been for Erdafitinib?
"As of now, there are 15 ongoing Erdafitinib trials with 1 in Phase 3. While some of the Seattle, Washington based research facilities are running out of funding, 3012 different locations worldwide are still trialing Erdafitinib."
Answered by AI
Will this be the first time a trial like this has been conducted?
"Erdafitinib is being trialed in 37 countries and 903 cities. The first Erdafitinib clinical trial occurred in 2015, sponsored by Janssen Research & Development, LLC. This initial study completed its Phase 2 drug approval stage with data collected from 255 patients. In the 5 years since then, 56 similar studies have been undertaken."
Answered by AI
Could you please share how many people are included in this clinical trial?
"The clinical trial is currently seeking participants, as noted on the website clinicaltrials.gov. The listing for this study was created on July 15th, 2021 and last updated October 12th, 2022. Currently, 40 people are needed to enroll at a single location."
Answered by AI
Has Erdafitinib been cleared by the FDA?
"Erdafitinib's safety is based on Phase 2 trial data, meaning that while there are no guarantees of efficacy, the medication has been proven safe in clinical settings."
Answered by AI
Are we able to sign up for the trial at this time?
"The trial is still recruiting patients, as evidenced by the information available on clinicaltrials.gov. The study was first posted on July 15th, 2021 and was last edited on October 12th, 2022. They are looking for 40 individuals across 1 site."
Answered by AI
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