NCT03801278

Brief Summary

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

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

First QC Date

January 9, 2019

Last Update Submit

December 9, 2021

Conditions

Recurrent Bladder Cancer

Keywords

Single patient

Interventions

FPA144DRUG

Bemarituzumab administration every two weeks

Also known as: Bemarituzumab

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

bemarituzumab

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Last Updated

December 13, 2021

Record last verified: 2021-12