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Margetuximab Expanded Access Program

Sponsor
MacroGenics (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT03133988
Collaborator
(none)

Study Details

Study Description

Brief Summary

The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

Condition or Disease Intervention/Treatment Phase
  • Biological: Margetuximab

Detailed Description

MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for MacroGenics to supply margetuximab for single patient use.

Study Design

Study Type:
Expanded Access
Official Title:
An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • MacroGenics may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies.

    • Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • MacroGenics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MacroGenics
    ClinicalTrials.gov Identifier:
    NCT03133988
    Other Study ID Numbers:
    • MGAH22-EA
    First Posted:
    Apr 28, 2017
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms
    Margetuximab

    Study Results

    No Results Posted as of Feb 22, 2022