Single Subject Neratinib in Bladder Cancer (NRR)

• Conditions: Bladder Cancer

• Registration Number: NCT01956253
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-09
• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-08
• Study Completion: 2014-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

North Carolina Cancer Hospital (UNC); 🇺🇸 Chapel Hill, North Carolina, United States