Overview

This trial is active, not recruiting.

Conditions myelofibrosis, polycythemia vera, thrombocytosis
Treatment ruxolitinib
Phase phase 1/phase 2
Target JAK
Sponsor Incyte Corporation
Start date June 2007
End date December 2007
Trial size 154 participants
Trial identifier NCT00509899, INCB 18424-251

Summary

To determine the safety, tolerability and effectiveness of ruxolitinib (INCB018424), administered orally to patients with Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) and Essential Thrombocythemia Myelofibrosis (PET-MF).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All participants received oral ruxolitinib. Patients began treatment with either 10 mg twice a day (bid), 15 mg bid, 25 mg bid, 50 mg bid, 25 mg once a day (qd), 50 mg qd, 100 mg qd, or 200 mg qd, depending on the time period when they entered the study. The doses were titrated based on efficacy and safety to a maximum of 25 mg bid for patients who entered the study after sufficient dosing information had been obtained to define the maximum dose for patients in the study. Patients could continue receiving treatment indefinitely if receiving benefit at a dose that continues to maintain benefit but does not exceed a maximum dose of 25 mg BID.
ruxolitinib INCB018424
5 and 25 mg tablets with a daily dosing range from 10 to 200 mg qd or bid.

Primary Outcomes

Measure
Number of Participants With Adverse Events (AEs)
time frame: From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.
Percentage of Participants With Clinical Improvement (CI) Over Time
time frame: Week 12, 24, 36, 48 and 60

Secondary Outcomes

Measure
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time
time frame: Baseline and Weeks 4, 12, 24, 48 and 60
Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time
time frame: Baseline, Weeks 4, 12, 24 and 48
Change From Baseline in Myelofibrosis Total Symptom Score at Week 24
time frame: Baseline and Week 24
Change From Baseline to Week 24 in Health-Related Quality of Life
time frame: Baseline and Week 24
Change From Baseline in Body Weight Over Time
time frame: Baseline and Weeks 4, 8, 12, 24, 36, 48 and 60.
Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: Baseline and Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with PMF or Post-PV/ET MF - Patients with myelofibrosis requiring therapy - Adequate bone marrow reserve Exclusion Criteria: - Received anti-cancer medications or investigational therapy in the past 14 days

Additional Information

Official title A Phase 1/2, Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)
Principal investigator Srdan Verstovsek, MD, PhD
Description This is a multicenter, open-label, non-randomized, dose escalation study of ruxolitinib, a small molecule Janus kinase (JAK) inhibitor, administered orally to patients with PMF, PPEV-MF or PET-MF. The study is comprised of 3 parts: Part 1: Dose escalation and determination of maximum tolerated dose (complete). Part 2: Exploration of alternative dosing schedules (ongoing). Part 3: Further evaluation of selected dose regimens, including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival (ongoing).
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Incyte Corporation.