Phase 2
N=154
Open Label Ruxolitinib (INCB018424) in Patients With Myelofibrosis and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Myelofibrosis · Polycythemia Vera · Thrombocytosis
Bottom Line
View on ClinicalTrials.gov: NCT00509899 ↗Enrolled (actual)
154
Serious AEs
46.1%
Results posted
Aug 2012
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 30; 35; 47; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
30; 35; 47; 5; 37; 21 | — |
| PRIMARY Percentage of Participants With Clinical Improvement (CI) Over Time |
36.0; 38.2; 38.1; 40.0; 34.4; 42.9 | — |
| SECONDARY Percentage of Participants Achieving ≥ 50% Reduction From Baseline in Spleen Palpation Length Over Time |
33.3; 38.2; 43.2; 75.0; 30.6; 29.6 | — |
| SECONDARY Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume Over Time |
0.0; 44.0; 0.0; 48.0; 0.0; 44.0 | — |
| SECONDARY Change From Baseline in Myelofibrosis Total Symptom Score at Week 24 |
-4.7; -5.6; 0.9; -6.5 | — |
| SECONDARY Change From Baseline to Week 24 in Health-Related Quality of Life |
14.81; 12.80; 0.63; 9.16 | — |
| SECONDARY Change From Baseline in Body Weight Over Time |
0.30; 1.59; 2.44; 4.44; 5.58; 6.35 | — |
| SECONDARY Change From Baseline to Week 24 in Eastern Cooperative Oncology Group (ECOG) Performance Status |
1; 0; 1; 0; 0; 4 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00509899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.