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Trial record 1 of 1 for:    NCT03133988
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Margetuximab Expanded Access Program

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ClinicalTrials.gov Identifier: NCT03133988
Expanded Access Status : Available
First Posted : April 28, 2017
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
MacroGenics

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
HER2-positive Breast Cancer 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 Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133988


Contacts
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Contact: Jan Baughman, MPH (650) 624-2776 expandedaccess@macrogenics.com
Contact: Emily Ashley (240) 552-8073 expandedaccess@macrogenics.com

Sponsors and Collaborators
MacroGenics
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Responsible Party: MacroGenics
ClinicalTrials.gov Identifier: NCT03133988    
Other Study ID Numbers: MGAH22-EA
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases