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Castration-Resistant Prostate CarcinomaPhase 2NCT03999515

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

A Phase 2 study testing Abiraterone Acetate, Enzalutamide and Erdafitinib in people with Castration-Resistant Prostate Carcinoma and Double-Negative Prostate Carcinoma, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Abiraterone Acetate, Enzalutamide and Erdafitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
27 Apr 2020to 6 Jun 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be >= 18 years of age prior to signing informed consent
  • 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 who have progressed on only one next-generation AR-directed therapy (e.g. abiraterone, enzalutamide) and who have not received taxane chemotherapy will be required to 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. Patients who have received two prior lines of AR-directed therapy and at least one prior taxane do not require histologic confirmation of DNPC. Note: transcript profiling methods for defining DNPC may be accepted per the PI's discretion
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer

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.

Read the 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.

Being tested
Abiraterone Acetate, Enzalutamide, Erdafitinib
Keywords
Prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone AcetateDrug

    Also called 154229-18-2, 17-(3-Pyridyl)-5, 16-androstadien-3beta-acetate, Androsta-5,16-dien-3-ol

    Given PO

  • EnzalutamideDrug

    Also called 915087-33-1, ASP9785, Benzamide, MDV3100

    Given PO

  • ErdafitinibDrug

    Also called Balversa, JNJ-42756493

    Given PO

Study groups in NCT03999515
Study groupRoleWhat they receive
Treatment (abiraterone acetate, enzalutamide, erdafitinib)ExperimentalPatients 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.
Receives: Drug: Abiraterone Acetate; Drug: Enzalutamide; Drug: Erdafitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    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.

    Measured: Up to 67 days

Secondary outcomes (5)

  1. Radiographic Progression Free Survival (PFS)

    Progression free survival is time to progressive disease. Disease progression is determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue metastases and Prostate Cancer Working Group 3 criteria for bone metastases. Median progression free survival will be calculated.

    Measured: Up to 67 days

  2. Time to Response

    Time to response is the time until a radiographic response occures as determined by RECIST 1.1 criteria. This cannot be determined since only two patients had re-staging scans on study and neither had a response.

    Measured: Up to 67 days

  3. Overall Survival (OS)

    Overall survival is time to death from any cause. Median overall survival survival will be calculated.

    Measured: From cycle 1, day 1 to the date of death, assessed up to 178 days

  4. Prostate-specific Antigen (PSA) Response

    PSA response will be defined by a > 50% reduction in PSA compared with baseline at any point during treatment. We will report the percentage of patients who achieve a PSA response.

    Measured: Baseline up to 73 days

  5. Incidence and Severity of Adverse Events (AEs)

    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.

    Measured: Within 14 days of end of treatment, an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2019
  2. Study start27 Apr 2020
  3. Primary completion6 Jun 2021
  4. Study completion6 Jun 2021

Why it stopped: Terminated due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03999515
Sponsor's protocol ID
RG1005038
Other IDs
NCI-2019-03812, 10288
Status last verified
Sep 2023
First submitted
21 Jun 2019
Last updated
28 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Enzalutamide and Erdafitinib in people with Castration-Resistant Prostate Carcinoma and Double-Negative Prostate Carcinoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to 67 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03999515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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