Individual Patient Compassionate Use of Fedratinib

NCT ID: NCT03723148

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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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.

Conditions

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Myelofibrosis

Interventions

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Oral Fedratinib

Oral fedratinib administered as directed by treating physician.

Intervention Type DRUG

Other Intervention Names

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FEDR

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role collaborator

Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celgene

Summit, New Jersey, United States

Site Status AVAILABLE

Countries

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United States

Central Contacts

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Celgene Medical Information

Role: CONTACT

1-888-771-0141

Other Identifiers

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FEDR

Identifier Type: -

Identifier Source: org_study_id

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