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Celgene

Individual Patient Compassionate Use of Fedratinib

Official Title: 
Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib
Brief Summary: 
This is an expanded access program (EAP) for eligible participants designed to provide access to Fedratinib.
Detailed Description: 

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Available
EA Type
Individual Patients
Myelofibrosis

Drug: Oral Fedratinib
Oral fedratinib administered as directed by treating physician.
Other Name: FEDR

Eligibility Criteria: 

Inclusion Criteria:

Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a
participant on a clinical trial prior to 31 Jan 2018.

Exclusion Criteria:

Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has
been treated with Fedratinib after 31 Jan 2018.

Eligibility Gender: 
All
Countries: 
United States
Locations: 

Celgene
Summit, New Jersey, 07901

Contacts: 

Celgene Medical Information
1-888-771-0141
medinfo@celgene.com

Celgene
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
EA Number: 
Keywords: 
Expanded Access, Compassionate Use
MeSH Terms: 
Primary Myelofibrosis
Disclaimer:
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.