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Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03999515
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : October 27, 2022
Janssen Research & Development, LLC
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies how well erdafitinib in combination with abiraterone acetate or enzalutamide works in treating patients with double negative prostate cancer. Erdafitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Testosterone can cause the growth of prostate cancer cells. Abiraterone acetate lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Enzalutamide blocks the use of testosterone by the tumor cells. Giving erdafitinib with abiraterone acetate or enzalutamide may work better in treating patients with prostate cancer compared to abiraterone acetate or enzalutamide alone.

Condition or disease Intervention/treatment Phase
Castration-Resistant Prostate Carcinoma Double-Negative Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Adenocarcinoma Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Drug: Abiraterone Acetate Drug: Enzalutamide Drug: Erdafitinib Phase 2

Detailed Description:

OUTLINE: Patients receive abiraterone acetate orally (PO) once daily (QD) or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : March 12, 2023
Estimated Study Completion Date : March 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment (abiraterone acetate, enzalutamide, erdafitinib)
Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
Given PO
Other Names:
  • 154229-18-2
  • 17-(3-Pyridyl)-5
  • 16-androstadien-3beta-acetate
  • Androsta-5,16-dien-3-ol
  • 17-(3-pyridinyl)-
  • acetate (ester)
  • CB7630
  • Yonsa
  • Zytiga
  • BR9004
  • BR9004-1
  • JNJ-212082

Drug: Enzalutamide
Given PO
Other Names:
  • 915087-33-1
  • ASP9785
  • Benzamide
  • MDV3100
  • Xtandi

Drug: Erdafitinib
Given PO
Other Names:
  • Balversa
  • JNJ-42756493

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 2 years ]
    Will be calculated as the percentage of patients, with 95% confidence intervals, achieving a complete response or partial response across the entire study population at any time.

Secondary Outcome Measures :
  1. Radiographic progression free survival (PFS) [ Time Frame: Up to 2 years ]
    Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue metastases and Prostate Cancer Working Group 3 criteria for bone metastases. Will be presented with Kaplan-Meier curves, and the median survival with 95% confidence interval (CI) will be calculated. Rates will be reported as percentages with 95% CI.

  2. Time to response [ Time Frame: Up to 2 years ]
    Will be assessed by RECIST 1.1.

  3. Overall survival (OS) [ Time Frame: From cycle 1, day 1 to the date of death, assessed up to 2 years ]
    Will be assessed by RECIST 1.1. Will be presented with Kaplan-Meier curves, and the median survival with 95% CI will be calculated. Rates will be reported as percentages with 95% CI.

  4. Prostate-specific antigen (PSA) response [ Time Frame: Baseline up to 2 years ]
    PSA response will be defined by a > 50% reduction in PSA compared with baseline at any point during treatment.

  5. Incidence and severity of adverse events (AEs) [ Time Frame: Within 14 days of end of treatment ]
    Will be assessed using version National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will characterize AEs by type and grade. Safety will be summarized as the severity and frequency of a given AE.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of histologically diagnosed prostatic adenocarcinoma
  • Participants must have evidence of castration resistant prostate cancer as evidenced by a confirmed rising PSA or radiographic progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e. =< 50 mg/dL)
  • Participants must have previously progressed on abiraterone acetate and/or enzalutamide, with PSA or radiographic progression on the most recent agent per PCWG3 criteria. If the most recent agent received was abiraterone or enzalutamide there should be no washout prior to initiating erdafitinib per protocol
  • Measurable disease as defined per RECIST v1.1 criteria
  • Subjects must have evidence of double-negative prostate cancer as defined by immunohistochemistry on biopsy. A fresh metastatic biopsy within 8 weeks is preferred; however, any archival tissue showing a DNPC phenotype will be acceptable for determining eligibility. Note: transcript profiling methods for defining DNPC may be accepted per the PI's discretion
  • Eastern Cooperative Oncology Group (ECOG) performance status score =< 2
  • Hemoglobin >= 8 g/dL (>= 5 mmol/L) (must be without red blood cell [RBC] transfusion within 7 days prior to the laboratory test)
  • Platelets >= 75 x 10^9/L
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) or =< 5 x ULN for subjects with liver metastases
  • Creatinine clearance >= 40 mL/min/1.73 m^2 based upon modified diet in renal disease formula calculation
  • Total bilirubin =< 1.5 x ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome
  • Corrected QT interval (corrected QT interval by Fridericia [QTcF] or QT corrected interval by the Bazett's formula [QTcB]) =< 480 msec based on the average of triplicate assessments performed approximately 5 minutes apart
  • Subjects must agree to use acceptable contraception
  • Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

  • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to randomization
  • Active malignancies (i.e., requiring treatment change in the last 24 months) other than malignancy under study (except skin cancers within the last 24 months that is considered completely cured)
  • Evidence of predominant small cell or neuroendocrine variant prostate cancer on most recent standard of care metastatic biopsy
  • Symptomatic central nervous system (CNS) metastases. Treated CNS metastases will be allowed if these are stable for at least 8 weeks prior to enrollment
  • Received prior FGFR inhibitor treatment or if the subject has known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
  • Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade
  • Has persistent phosphate level > ULN during screening (on 2 consecutive assessments at least 1 week apart, within 14 days of treatment and prior to cycle 1 day 1) and despite medical management
  • Has a history of or current uncontrolled cardiovascular disease including:

    • Unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cardiac arrest, or known congestive heart failure class III-V within the preceding 3 months; cerebrovascular accident or transient ischemic attack within the preceding 3 months
    • Pulmonary embolism or other VTE (venous thromboembolism) within the preceding 2 months
  • Has known active acquired immune deficiency syndrome (AIDS) (human immunodeficiency virus [HIV] infection)
  • Hepatitis B infection as defined according to the American Society of Clinical Oncology guidelines. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status. Hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-ribonucleic acid [RNA] quantitation positive) or known to have a history of hepatitis C. If positive, further testing of quantitative levels to rule out positivity is required
  • Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, hot flashes, grade 1 neuropathy, grade 1-2 hearing loss)
  • Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
  • Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration. (Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate
  • Any serious underlying medical condition, such as:

    • Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection
    • Active autoimmune disease or a documented history of autoimmune disease
    • Psychiatric conditions (e.g., alcohol or drug abuse), dementia, or altered mental status
  • Any other issue that would impair the ability of the subject to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Patient, who, in the opinion of their treating physician, requires immediate treatment (e.g. those with extensive liver metastases)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999515

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Contact: Andrea Rivero (206) 667-3490 ariveroc@seattlecca.org
Contact: Michael Schweizer (206)606-6252 schweize@uw.edu

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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Andrea Rivero    206-667-3490    ariveroc@seattlecca.org   
Principal Investigator: Michael Schweizer         
Sponsors and Collaborators
University of Washington
Janssen Research & Development, LLC
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Principal Investigator: Michael Schweizer Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03999515    
Other Study ID Numbers: RG1005038
NCI-2019-03812 ( Registry Identifier: NCI / CTRP )
10288 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Washington:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors