Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDavid Einstein, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

David Einstein, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

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

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Treatment Details

Interventions

Neratinib (Tyrosine Kinase Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: NeratinibExperimental Treatment1 Intervention

The 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