Bladder CancerNCT01956253
Single Subject Neratinib in Bladder Cancer (NRR)
A study testing Neratinib in people with Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Neratinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- none
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Cancer Hospital (UNC)
Chapel Hill, North Carolina, 27599
About this study
Official title: Single Subject Neratinib in Bladder Cancer
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.
- Conditions
- Bladder Cancer
- Being tested
- Neratinib
- Keywords
- Bladder Cancer, Neratinib, 13-2526
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeratinibDrug
240 mg orally once daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Kim, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956253
- Sponsor's protocol ID
- 13-2526
- Status last verified
- Mar 2017
- First submitted
- 25 Sep 2013
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Subject Neratinib in Bladder Cancer
- ClinicalTrials.gov ID
- NCT01956253
- Acronym / sponsor ID
- 13-2526
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Neratinib, 13-2526
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- none
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neratinib240 mg orally once daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Lineberger Comprehensive Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Kim, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neratinib in people with Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.