Clinical trial · Interventional
Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
An Open-label Assessment of Once-daily Dosing of a Sustained Release (SR) Formulation of INCB018424 in Patients With Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, and Post-polycythemia Vera Myelofibrosis
NCT01340651CI-TRIAL-00013982completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ruxolitinib 25 mg SR/10, 15, or 20 mg IR
- description
- Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily. Participants who continued to demonstrate benefit in the opinion of the investigator could remain on ruxolitinib IR until the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
- interventionNames
- Drug: Ruxolitinib
Primary outcomes (2)
- measure
- Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16
- timeFrame
- Baseline to Week 16
- measure
- Overall Response (OR) at Week 16
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.