Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer

Prostate Cancer Clinical Trial

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

Status Withdrawn

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Castration-resistant Prostate Cancer
• Metastatic Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Metastatic
• Prostatic Neoplasms

• NCT number: NCT04781374
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 21, 2021
• Completion date: September 24, 2021