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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
Five Prime Therapeutics, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Recurrent Bladder Cancer focused on measuring Single patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2019
    Last Updated
    December 9, 2021
    Sponsor
    Five Prime Therapeutics, Inc.
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    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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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