An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer (FPA144)
Primary Purpose
Recurrent Bladder Cancer
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
FPA144
Sponsored by
About this trial
This is an expanded access trial for Recurrent Bladder Cancer focused on measuring Single patient
Eligibility Criteria
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:
1. Pregnancy and lactation
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03801278
First Posted
January 9, 2019
Last Updated
December 9, 2021
Sponsor
Five Prime Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03801278
Brief Title
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Acronym
FPA144
Official Title
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Five Prime Therapeutics, Inc.
4. Oversight
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Bladder Cancer
Keywords
Single patient
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FPA144
Other Intervention Name(s)
Bemarituzumab
Intervention Description
Bemarituzumab administration every two weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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:
1. Pregnancy and lactation
12. IPD Sharing Statement
Learn more about this trial
An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
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