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. Expanded access is only available in markets where fedratinib is not yet approved.

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.

Individual Patients

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
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Summit, New Jersey, United States


Celgene Medical Information

Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
NCT Number
Expanded Access
Compassionate Use
MeSH Terms
Primary Myelofibrosis