CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 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/NCT01392443
NCT01392443Phase 2Completed
CompareCT.gov

A Multi-national Open-label Phase II Study of the JAK Inhibitor INC424 in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis

Novartis Pharmaceuticals·interventional·Posted Jul 12, 2011·Updated Sep 3, 2019

In Brief

A Phase 2 clinical trial evaluating Ruxolitinib for Primary Myelofibrosis (MF) and 2 related conditions. Completed, enrolled 120 participants across 26 sites in 4 countries.

Detailed Summary

The objective of this study was to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume was also assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF
CountriesChina, Japan, South Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2011
Enrollment StartOct 14, 2010
Primary CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 15.0 years ago

Interventions

Ruxolitinibdrug

INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength was 5 mg/tablet INC424 phosphate (free base equivalent).