Clinical Trial: A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-label Clinical Study of the JAK Inhibitor Ruxolitinib (INC424) in Patients With Primary Myelofibrosis, Post-polycythemia Vera Mye

Brief Summary: This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Charge in Spleen Size From Baseline at Specified Week [ Time Frame: Baseline, 24 weeks ]
    Number of patients with spleen length reduced by ≥ 50% at specified week
  • Charge in Spleen Size From Baseline up to the Specified Week [ Time Frame: Baseline, 24 weeks ]
    Number of patients with spleen length reduced by ≥ 50% up to specified week
  • Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time [ Time Frame: 24 weeks ]
    The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60
  • Summary of Summary of EORTC QLQ-C30 Responses by Time [ Time Frame: 24 weeks ]
    The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.


Original Secondary Outcome:

  • Charge in spleen size from baseline [ Time Frame: Baseline, 24 weeks ]
  • Clinical symptoms will be evaluated using th seven-day modified MFSAF questionnaires [ Time Frame: 24 weeks ]
  • Quality of Life will be evaluated using the EORTC QLQ-C30 [ Time Frame: 24 weeks ]


Information By: Novartis

Dates:
Date Received: March 12, 2014
Date Started: April 2014
Date Completion:
Last Updated: May 26, 2016
Last Verified: May 2016