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Metastatic Prostate AdenocarcinomaPhase 2NCT04781374

Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 2 study testing Neratinib in people with Metastatic Prostate Adenocarcinoma and Castration-resistant Prostate Cancer, run by Beth Israel Deaconess Medical Center at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study is examining whether Neratinib has any activity in participants with prostate cancer that has spread and is no longer responding to hormonal treatment. The names of the study drug involved in this study is neratinib. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Neratinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
21 May 2021to 24 Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed metastatic prostate adenocarcinoma (secondary components of variant histology are acceptable).
  • Castration-resistance, with progression on medical/surgical castration and confirmed baseline testosterone <50ng/dL
  • Ongoing castration, either with prior orchiectomy or ongoing gonadotropin releasing hormone (GnRH) agonist/antagonist therapy as per investigator discretion
  • Anti-resorptive therapy (e.g. denosumab, bisphosphonates) is allowable at any point
  • Prior progression on (or intolerance of) at least one androgen-receptor signaling inhibitor(i.e. abiraterone, enzalutamide, apalutamide, darolutamide). Progression is per investigator and can include prostate specific antigen (PSA), symptomatic, and/or radiographic progression. There is no limit to prior therapies, nor any requirement on taxane treatments.
  • Positive biomarker (phospho human epidermal growth factor receptor 2, pHER2) assessment on baseline tissue. Archival tissue is acceptable but must have been acquired during or after prior abiraterone and/or enzalutamide therapy and must meet tissue specifications outlined in the biomarker assessment section of the protocol. If suitable archival tissue is not available, then the patient must be willing to undergo a research biopsy to obtain tissue for biomarker assessment.
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  • Evaluable for response, defined as at least one of the following:
  • Baseline PSA >=2.0 ng/mL
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Ability to understand and willingness to sign informed consent.
  • Willingness to undergo research biopsy on study, as well as at baseline if needed to obtain tissue for biomarker assessment.
  • Age >=18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Adequate organ and marrow function as defined below:
  • leukocytes ≥2,000/mcL
  • absolute neutrophil count ≥1,500/mcL
  • platelets ≥100,000/mcL
  • total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), unless participant has known or suspected Gilbert's syndrome
  • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or <=5 x ULN if liver metastases present
  • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min
  • Male participants must agree to use contraception with any female partners who are of reproductive potential prior to the study entry, for the duration of the study participation, and 6 months after completion of administration.
  • Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Participants with brain metastases are eligible if (1) brain metastases are asymptomatic and patients are on a stable dose of corticosteroids (if needed) for 14 days prior to enrollment, or (2) brain metastases have been treated with local therapy and follow-up brain imaging shows no evidence of progression.
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Participants must be able to swallow pills.

Who cannot join

  • Use of a strong CYP3A4/CYP2C8 inducer/inhibitor within 3 half-lives prior to first dose of study treatment
  • Participants who are receiving any other investigational agents
  • History of allergic reaction to HER2 inhibitors
  • Child-Pugh class C hepatic impairment
  • Current use of a proton pump inhibitor (no specific wash-out period)
  • Corrected QTc interval >450 msec with institutional standard correction formula. One EKG is sufficient. In the case of potentially reversible causes of QT prolongation (e.g. medications, electrolyte abnormalities), EKG may be repeated once during screening and that result may be used to determine eligibility.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Uncontrolled baseline diarrhea or uncontrolled predisposition to intermittent diarrhea, e.g. uncontrolled inflammatory bowel diseases.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Center

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase 2 Study of Neratinib in Patients With Metastatic Castration Resistant Prostate Cancer and Increased Human Epithelial Growth Factor Receptor 2 (HER2) Signaling

This research study is examining whether Neratinib has any activity in participants with prostate cancer that has spread and is no longer responding to hormonal treatment.

  • The names of the study drug involved in this study is neratinib.
Read the detailed description

In this research study, investigators are testing neratinib in prostate cancer that has spread and is no longer responding to hormonal therapies. This research study involves testing tumors for evidence of increased HER2 signaling, and treating those who do have increased HER2 signaling with a targeted therapy.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits.

  • The names of the study drug involved in this study is neratinib. It is expected that about 14 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease.

"Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved neratinib for this specific disease but it has been approved for other uses.

Being tested
Neratinib
Keywords
Metastatic Prostate Adenocarcinoma, Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Cancer Metastatic
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • NeratinibDrug

    Also called Nerlynx

    Oral, once daily with 28 consecutive days defined as a treatment cycle, dosage per protocol ,

Study groups in NCT04781374
Study groupRoleWhat they receive
NeratinibExperimentalThe research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. - Neratinib-once daily with 28 consecutive days defined as a treatment cycle
Receives: Drug: Neratinib

What is being measured

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

  1. Response Rate to Neratinib

    defined by PSA response and/or radiographic response after three 28-day cycles of treatment.

    Measured: 84 days

Secondary outcomes (6)

  1. Best PSA response

    the best percent change in PSA from baseline while on neratinib among PSA evaluable patients will be visualized for each individual patient using waterfall plot

    Measured: 24 Months

  2. Best Radiographic Response

    the maximum change of tumor area from baseline while on neratinib among target disease evaluable patients will be visualized for each individual patient using waterfall plot.

    Measured: Baseline, Every 3 Cycles through study completion, up to 24 months.

  3. Duration of Response

    patients who met either duration of biochemical response or duration of radiographic response until biochemical or radiographic response criteria are met, will be presented using Kaplan-Meier method.

    Measured: Baseline, Every 3 Cycles through study completion, up to 24 months.

  4. Progression Free Survival

    Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression by PCWG3 criteria or death due to any cause.

    PCWG3 progression is defined as when the treating physician feels the patient is "no longer clinically benefitting" (NLCB) from therapy. Generally, this is understood as radiographic or clinical/symptomatic progression (i.e. not PSA progression alone), but PCWG3 criteria allow treatment beyond radiographic progression when the treating physician feels that the patient is continuing to derive clinical benefit from therapy (compared to other available treatments or no treatment). Participants alive without disease progression are censored at date of last disease evaluation

    Measured: 24 Months

  5. Overall Survival

    Overall Survival (OS) is defined as the time from registration to death due to any cause or censored at date last known alive

    Measured: 6 Months

  6. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0

    For toxicity reporting, all adverse events will be reported using CTCAE version 5.0

    Measured: Baseline, through study (up to 24 Months, and until the end of the 30-day post-treatment follow-up.

Timeline

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

  1. First posted4 Mar 2021
  2. Study start21 May 2021
  3. Primary completion24 Sep 2021
  4. Study completion24 Sep 2021

Why it stopped: Withdrawal of funding

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04781374
Sponsor's protocol ID
20-659
Status last verified
Jul 2023
First submitted
26 Feb 2021
Last updated
11 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neratinib in people with Metastatic Prostate Adenocarcinoma and Castration-resistant Prostate Cancer, run by Beth Israel Deaconess Medical Center at 3 sites 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 27 inclusion and 8 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: withdrawn, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Response Rate to Neratinib (time frame: 84 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 NCT04781374.

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 11 Jul 2023.

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