Recurrent Bladder CancerFPA144NCT03801278
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
A study testing FPA144 in people with Recurrent Bladder Cancer, run by Five Prime Therapeutics, Inc..
Trial summary
This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent Bladder Cancer
- What is being tested?
- FPA144
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Adult, Older adult
Who may be able to join
- Understand and sign an Institutional Review Board-approved informed consent form prior to receiving bemarituzumab
- Previously enrolled on the FPA144-001 study, received bemarituzumab and obtained clinical benefit from the investigational product (IP) administration
Who cannot join
- 1. Pregnancy and lactation
About this study
This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer
Read the detailed description
This protocol is intended to provide access to bemarituzumab (FPA144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on FPA144-001. That study is closing and this expanded access protocol allows this single patient to continue receiving this agent.
- Conditions
- Recurrent Bladder Cancer
- Being tested
- FPA144
- Keywords
- Single patient
- 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.
FPA144Drug
Also called Bemarituzumab
Bemarituzumab administration every two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Bladder CancerStudies of the same condition, open and under way.
- 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
- Five Prime Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801278
- Sponsor's protocol ID
- FPA144-006
- Acronym
- FPA144
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2019
- Last updated
- 13 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
- ClinicalTrials.gov ID
- NCT03801278
- Acronym / sponsor ID
- FPA144 / FPA144-006
- Conditions
- Recurrent Bladder Cancer
- Keywords
- Single patient
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Five Prime Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 11 Jan 2019 (actual)
- 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 is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer
Detailed description
This protocol is intended to provide access to bemarituzumab (FPA144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on FPA144-001. That study is closing and this expanded access protocol allows this single patient to continue receiving this agent.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Understand and sign an Institutional Review Board-approved informed consent form prior to receiving bemarituzumab
- Previously enrolled on the FPA144-001 study, received bemarituzumab and obtained clinical benefit from the investigational product (IP) administration
Key exclusion criteria (1 listed)
- 1. Pregnancy and lactation
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 |
|---|---|---|
| FPA144Also: BemarituzumabBemarituzumab administration every two weeks | 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 13 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FPA144 in people with Recurrent Bladder Cancer, run by Five Prime Therapeutics, Inc..
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 2 inclusion and 1 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 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 13 Dec 2021.