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Margetuximab Expanded Access Program

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ClinicalTrials.gov Identifier: NCT03133988
Expanded Access Status : Temporarily not available
First Posted : April 28, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
MacroGenics

Brief Summary:
The purpose of the Expanded Access program is to provide margetuximab to patients with breast cancer and other HER2+ carcinomas who are not otherwise eligible for a MacroGenics sponsored study and the potential benefit justifies the potential risk of treatment use.

Condition or disease Intervention/treatment
HER2-positive Breast Cancer Neoplasm Metastasis HER2-positive Carcinoma 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.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: An Expanded Access (Compassionate Use) Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer and Other HER2+ Carcinomas in Single, Individually-approved Patients

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Margetuximab
    anti-HER2 monoclonal antibody
    Other Name: MGAH22

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

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:


No Contacts or Locations Provided

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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT03133988     History of Changes
Other Study ID Numbers: MGAH22-EA
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs