CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,233 enrolled
Drug / intervention
INC424drug
Likely dose
INC424 20 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/NCT01493414
NCT01493414Phase 3Completed
CompareCT.gov

An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).

Novartis Pharmaceuticals·interventional·Posted Dec 16, 2011·Updated Apr 26, 2019

In Brief

A Phase 3 clinical trial evaluating INC424 for Myelofibrosis. Completed, enrolled 2,233 participants across 273 sites in 25 countries.

Detailed Summary

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelofibrosis
CountriesAlgeria, Argentina, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Germany, Greece, Hungary, Ireland, Israel, Italy, Mexico, Morocco, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Thailand, Tunisia
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2011
Enrollment StartAug 16, 2011
Primary CompletionJan 26, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 14.5 years ago

Interventions

INC424drug

All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.