An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Sponsor
Five Prime Therapeutics, Inc. (Industry)
Overall Status
No longer available
CT.gov ID
NCT03801278
Collaborator
(none)
Study Details
Study Description
Brief Summary
This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Study Type:
Expanded Access
Official Title:
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Inclusion Criteria:
-
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
Exclusion Criteria:
- Pregnancy and lactation
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Five Prime Therapeutics, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03801278
Other Study ID Numbers:
- FPA144-006
First Posted:
Jan 11, 2019
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Keywords provided by Five Prime Therapeutics, Inc.
Additional relevant MeSH terms: