Back to resultsSingle Subject Neratinib in Bladder Cancer (NRR)
Primary Purpose
Bladder Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Neratinib
Sponsored by
About this trial
This is an expanded access trial for Bladder Cancer focused on measuring Bladder Cancer, Neratinib, 13-2526
Eligibility Criteria
Inclusion Criteria:
* none
Exclusion Criteria:
* none
We have received FDA approval for a single subject Investigational New Drug (IND) Application to treat a specific patient with the HER2 kinase inhibitor neratinib. Therefore there is no inclusion / exclusion criteria.
Sites / Locations
- North Carolina Cancer Hospital (UNC)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01956253
First Posted
September 25, 2013
Last Updated
March 10, 2017
Sponsor
UNC Lineberger Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01956253
Brief Title
Single Subject Neratinib in Bladder Cancer (NRR)
Official Title
Single Subject Neratinib in Bladder Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
No longer available
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
4. Oversight
5. Study Description
Brief Summary
This study will be a single subject study to evaluate the efficacy of the HER2 kinase inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene fusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Bladder Cancer, Neratinib, 13-2526
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neratinib
Intervention Description
240 mg orally once daily
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
* none
Exclusion Criteria:
* none
We have received FDA approval for a single subject Investigational New Drug (IND) Application to treat a specific patient with the HER2 kinase inhibitor neratinib. Therefore there is no inclusion / exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Kim, MD
Organizational Affiliation
UNC Lineberger Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Cancer Hospital (UNC)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.med.unc.edu/
Description
Lineberger Comprehensive Cancer Center
Learn more about this trial
Single Subject Neratinib in Bladder Cancer (NRR)
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