Single Subject Neratinib in Bladder Cancer (NRR)
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 25, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 14, 2017
March 1, 2017
2 months
September 25, 2013
March 10, 2017
Conditions
Keywords
Interventions
240 mg orally once daily
Eligibility Criteria
You may qualify if:
- \* none
You may not qualify if:
- \* none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Carolina Cancer Hospital (UNC)
Chapel Hill, North Carolina, 27599, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Kim, MD
UNC Lineberger Comprehensive Cancer Center
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
October 8, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2013
Study Completion
June 1, 2014
Last Updated
March 14, 2017
Record last verified: 2017-03