CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
ruxolitinibdrug
Likely dose
ruxolitinib 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02966353
NCT02966353Phase 2Completed
CompareCT.gov

A Multicenter Phase II, Open Label, Single Arm Study to Evaluate the Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Novartis Pharmaceuticals·interventional·Posted Nov 17, 2016·Updated Apr 30, 2020

In Brief

A Phase 2 clinical trial evaluating ruxolitinib for Primary Myelofibrosis and 2 related conditions. Completed, enrolled 51 participants across 20 sites in 11 countries.

Detailed Summary

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis
CountriesAustria, Belgium, Bulgaria, Canada, Germany, Greece, Italy, Japan, Russia, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2016
Enrollment StartMar 31, 2017
Primary CompletionJul 24, 2018
Study CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.6 years ago

Interventions

ruxolitinibdrug

Ruxolitinib was supplied in 5 mg tablets to be taken orally approximately 12 hours apart (morning and night)