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NCT03755518 · ClinicalTrials.gov registry record · Phase 3

A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

A Phase 3 study, sponsored by Celgene.

Terminated
Registry status
Phase 3
Development phase
38
Enrollment target

NCT03755518 is a Phase 3 study that was terminated before completion, run by Celgene. The registered enrollment target is 38 participants.

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The verdict

NCT03755518, a Phase 3 study, was terminated before completion, sponsored by Celgene.

TERMINATED
Registry status
Phase 3
Development phase
38 participants
Enrollment target

Study Summary

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction in spleen size and one of the secondary objectives is to evaluate the safety of fedratinib.

Interventions

  • DRUG FEDRATINIB

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-03-27
Est. Completion 2023-11-08
Phase Phase 3

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT03755518

The ClinicalTrials.gov registry entry for NCT03755518 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which FEDRATINIB is the first listed.

NCT03755518 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03755518 about?

NCT03755518 is a clinical study titled "A Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib". This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (...

What is the current status of trial NCT03755518?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2019-03-27. Estimated completion is 2023-11-08.

What interventions are being tested in trial NCT03755518?

The interventions under investigation include: FEDRATINIB (DRUG).

Who is sponsoring clinical trial NCT03755518?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.