MPN (Myeloproliferative Neoplasms)
Conditions
Keywords
Primary Myelofibrosis, PMF, Post Polycythemia Vera Fibrosis, PPV-MF, Post Essential Thrombocythemia Myelofibrosis, PET-MF
Brief summary
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
Interventions
DRUGitacitinib
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy. * Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count \<10% at both Screening and Baseline hematology assessments. * Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14. * Subjects must have hemoglobin value \>/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count \>/=50x10\^9/L and absolute neutrophil count (ANC) \>/= 1x10\^9/L. * Subjects must have palpable spleen or history of splenectomy * Active symptoms at the screening visit
Exclusion criteria
* Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively. * Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy. * Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary | Baseline and Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume | Baseline, Week 12 and Week 24 |
| Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level | Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit. |
| Safety and tolerability of itacitinib as measured by adverse events. | Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase). |
Countries
Australia, Canada, United States
Outcome results
None listed