Phase 2
N=41
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01340651 ↗Enrolled (actual)
41
Serious AEs
18.3%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 — 78.0 Percentage of 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
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16 |
78.0 | — |
| PRIMARY Overall Response (OR) at Week 16 |
17.1; 80.5; 2.4 | — |
| SECONDARY Change From Baseline in Spleen Volume at Week 16 |
-22.3 | — |
| SECONDARY Change From Baseline in Spleen Length at Week 16 |
-29.6 | — |
| SECONDARY Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline |
26.8 | — |
| SECONDARY Change From Baseline in the Total Symptom Score at Week 16 |
-50.4 | — |
| SECONDARY Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16 |
43.9 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1 |
319 | — |
| SECONDARY Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1 |
2.0 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1 |
1550 | — |
Summary
The purpose of this study is to determine the safety and tolerability of ruxolitinib (INCB018424) sustained release (SR) formulation in participants with primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF), and post-essential thrombocythemia MF (PET-MF).
Eligibility Criteria
Inclusion Criteria
- Participants 18 years of age or older.
- Participants must be diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia myelofibrosis (PPV-MF), or post-polycythemia vera myelofibrosis (PET-MF).
- Participants with myelofibrosis requiring therapy must be classified as high risk (3 or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or intermediate risk level 1 (1 prognostic factor)defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT).
- Participants must have a palpable spleen measuring 5 cm or greater below the costal margin.
Exclusion Criteria
- Participants with a life expectancy of less than 6 months.
- Participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child.
- Participants with inadequate bone marrow reserve.
- Participants with history of platelet counts < 50,000/μL, platelet transfusion(s), or an absolute neutrophil count < 500/μL in the month prior to Screening.
- Participants with inadequate liver or renal function at Screening and Baseline visits.
Data sourced from ClinicalTrials.gov (NCT01340651). 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.