Individual Patient Compassionate Use of Fedratinib
Sponsor
Celgene (Industry)
Overall Status
Available
CT.gov ID
NCT03723148
Collaborator
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation (Industry)
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Expanded Access
Official Title:
Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Celgene | Summit | New Jersey | United States | 07901 |
Sponsors and Collaborators
- Celgene
- Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT03723148
Other Study ID Numbers:
- FEDR
First Posted:
Oct 29, 2018
Last Update Posted:
Sep 18, 2020
Last Verified:
Sep 1, 2020
Keywords provided by Celgene
Additional relevant MeSH terms: