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Individual Patient Compassionate Use of Fedratinib

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03723148
Enrollment
Unknown
Registered
2018-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Keywords

Expanded Access, Compassionate Use

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.

Interventions

DRUGOral Fedratinib

Oral fedratinib administered as directed by treating physician.

Sponsors

Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
CollaboratorINDUSTRY
Celgene
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Countries

United States

Contacts

Primary ContactCelgene Medical Information
medinfo@celgene.com1-888-771-0141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026