MyelofibrosisNCT03723148
Individual Patient Compassionate Use of Fedratinib
A study testing Oral Fedratinib in people with Myelofibrosis, run by Celgene at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Oral Fedratinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.
Who cannot join
- Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib
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.
Read the 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.
- Conditions
- Myelofibrosis
- Being tested
- Oral Fedratinib
- Keywords
- Expanded Access, Compassionate Use
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral FedratinibDrug
Also called FEDR
Oral fedratinib administered as directed by treating physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723148
- Sponsor's protocol ID
- FEDR
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib
- ClinicalTrials.gov ID
- NCT03723148
- Acronym / sponsor ID
- FEDR
- Conditions
- Myelofibrosis
- Keywords
- Expanded Access, Compassionate Use
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.
Key exclusion criteria (1 listed)
- Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral FedratinibAlso: FEDROral fedratinib administered as directed by treating physician. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Fedratinib in people with Myelofibrosis, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celgene Medical Information (1-888-771-0141, medinfo@celgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.