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

NCT ID: NCT03801278

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Recurrent Bladder Cancer

Interventions

FPA144

Bemarituzumab administration every two weeks

Intervention Type: DRUG

Other Intervention Names

Bemarituzumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Five Prime Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FPA144-006

Identifier Type: -

Identifier Source: org_study_id