Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Castration Resistant Prostate Cancer
  • Metastatic Prostate Adenocarcinoma
  • Prostate Cancer
  • Prostate Cancer Metastatic
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 targe...

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.

Tracking Information

NCT #
NCT04781374
Collaborators
Puma Biotechnology, Inc.
Investigators
Principal Investigator: David Einstein, MD Beth Israel Deaconess Medical Center