Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781374
Status:
WITHDRAWN
Last Update Posted:
2023-07-11
First Post:
2021-02-26
Brief Title:
Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
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WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- The names of the study drug involved in this study is neratinib
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 US Food and Drug Administration FDA has not approved neratinib for this specific disease but it has been approved for other uses
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 US Food and Drug Administration FDA has not approved neratinib for this specific disease but it has been approved for other uses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None