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Individual Patient Compassionate Use of Fedratinib

Primary Purpose

Myelofibrosis

Status

Available

Phase

Locations

United States

Study Type

Expanded Access

Intervention

Oral Fedratinib

About this trial

This is an expanded access trial for Myelofibrosis focused on measuring Expanded Access, Compassionate Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

Celgene

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT03723148

First Posted

October 25, 2018

Last Updated

September 17, 2020

Sponsor

Celgene

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03723148

Brief Title

Individual Patient Compassionate Use of Fedratinib

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelofibrosis

Keywords

Expanded Access, Compassionate Use

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oral Fedratinib

Other Intervention Name(s)

FEDR

Intervention Description

Oral fedratinib administered as directed by treating physician.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Celgene Medical Information

Phone

1-888-771-0141

medinfo@celgene.com

Facility Information:

Facility Name

Celgene

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Individual Site Status

Available

12. IPD Sharing Statement

Learn more about this trial

Individual Patient Compassionate Use of Fedratinib

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