Margetuximab Expanded Access Program
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03133988|
Expanded Access Status : Temporarily not available
First Posted : April 28, 2017
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
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|
|HER2-positive Breast Cancer Neoplasm Metastasis HER2-positive Carcinoma|
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 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|
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