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NCT03723148 Clinical Trial

Individual Patient Compassionate Use of Fedratinib

Myelofibrosis Clinical Trial

Official title:
Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03723148
Other study ID # FEDR
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date September 2020
Source Celgene
Contact Celgene Medical Information
Phone 1-888-771-0141
Email medinfo@celgene.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral Fedratinib
Oral fedratinib administered as directed by treating physician.

Locations
Country Name City State
United States Celgene Summit New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Celgene Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

Country where clinical trial is conducted

United States, 

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