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Individual Patient Compassionate Use of Fedratinib

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ClinicalTrials.gov Identifier: NCT03723148
Expanded Access Status : Available
First Posted : October 29, 2018
Last Update Posted : September 18, 2020
Sponsor:
Collaborator:
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Information provided by (Responsible Party):
Celgene

Study Description
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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.


Condition or disease Intervention/treatment
Myelofibrosis Drug: Oral 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.
Study Design
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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: Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Oral Fedratinib
    Oral fedratinib administered as directed by treating physician.
    Other Name: FEDR
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Contacts and Locations
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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): NCT03723148


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

Locations
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United States, New Jersey
Celgene Available
Summit, New Jersey, United States, 07901
Sponsors and Collaborators
Celgene
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03723148    
Other Study ID Numbers: FEDR
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Keywords provided by Celgene:
Expanded Access
Compassionate Use
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases