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Clinical Trial Details — Status: No longer available

Administrative data

NCT number NCT01956253
Other study ID # 13-2526
Secondary ID
Status No longer available
Phase N/A
First received September 25, 2013
Last updated March 10, 2017
Start date July 2013
Est. completion date June 2014

Study information

Verified date March 2017
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


Recruitment information / eligibility

Status No longer available
Enrollment 0
Est. completion date June 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Neratinib
240 mg orally once daily

Locations

Country Name City State
United States North Carolina Cancer Hospital (UNC) Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

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