Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
Last updated on July 2021Recruitment
- 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