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INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

NCT01493414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2233

Last updated 2019-04-26

Study results available
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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.

Conditions

Interventions

DRUG

INC424

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-16
Primary Completion
2017-01-26
Completion
2017-01-26

Countries

  • Algeria
  • 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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01493414 on ClinicalTrials.gov