An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer

Recurrent Bladder Cancer Clinical Trial

— FPA144  

Official title:

An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03801278
• Other study ID #: FPA144-006
• Status: No longer available

Study information

• Verified date: December 2021
• Source: Five Prime Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

This is an open-label, expanded access protocol to continue administration of bemarituzumab (FPA144) in a single patient with recurrent bladder cancer

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Understand and sign an Institutional Review Board-approved informed consent form prior to receiving bemarituzumab

2. 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

Related Conditions & MeSH terms

• Recurrent Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• FPA144
Bemarituzumab administration every two weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Five Prime Therapeutics, Inc.