Phase 2
N=66
Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
MPN (Myeloproliferative Neoplasms)
Bottom Line
View on ClinicalTrials.gov: NCT01348490 ↗Enrolled (actual)
66
Serious AEs
14.4%
Results posted
Jan 2020
Primary outcome: Primary: Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose — -11.6; -17.4; -22.4; -13.4 Percentage change from baseline — p=0.0250
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 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose |
-11.6; -17.4; -22.4; -13.4 | 0.0250 sig |
| PRIMARY Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose |
-6.35; -39.51; -47.54; 7.95 | 0.6887 |
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAE) |
93.3; 74.2; 61.1; 77.3; 55.6 | — |
| PRIMARY Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03) |
23.1; 3.0; 5.7; 4.7; 0.0 | — |
| PRIMARY Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03 |
6.7; 3.0; 1.9; 2.3; 11.1 | — |
| SECONDARY Percent Change in Spleen Volume at Week 24 Compared to Baseline |
-17.8 | <0.0001 sig |
| SECONDARY Percent Change in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline |
-27.90 | 0.0028 sig |
| SECONDARY Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 24 Compared to Baseline |
4.8; 0.0; 24.2; 28.6 | — |
| SECONDARY Percentage of Participants With ≥10% Reduction in Spleen Volume at Week 24 Compared to Baseline |
42.9; 66.7; 63.6; 28.6 | — |
| SECONDARY Percentage of Participants With ≥ 50% Improvement in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline |
28.6; 0.0; 44.1; 28.6 | — |
| SECONDARY Change in Spleen Length Measured by Palpation |
11.48; 14.00; 13.13; 14.71; -3.40; -4.00 | — |
| SECONDARY Percent Change From Baseline in Spleen Length Measured by Palpation |
-38.61; -26.62; -21.88; -1.42; -50.64; -37.95 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score at Each Visit |
2.8; 2.8; 2.6; 3.3; 2.7; 2.3 | — |
Summary
To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
- Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
- INR 1.5 x upper limit of normal at study entry.
Data sourced from ClinicalTrials.gov (NCT01348490). 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.