Clinical trial · Interventional
An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
NCT01633372CI-TRIAL-00053581completedPhase 2ClinicalTrials.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)
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
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 |
|---|---|---|---|
| MPN (Myeloproliferative Neoplasms) | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| itacitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- itacitinib 100 mg
- description
- itacitinib 100 mg twice a day
- interventionNames
- Drug: itacitinib
- type
- EXPERIMENTAL
- label
- itacitinib 200 mg
- description
- itacitinib 200 mg twice a day
- interventionNames
- Drug: itacitinib
- type
- EXPERIMENTAL
- label
- itacitinib 300 mg
- description
- itacitinib 300 mg once a day
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMascarenhas JO, Talpaz M, Gupta V, Foltz LM, Savona MR, Paquette R, Turner AR, Coughlin P, Winton E, Burn TC, O'Neill P, Clark J, Hunter D, Assad A, Hoffman R, Verstovsek S. Primary analysis of a phase II open-label trial of INCB039110, a selective JAK1 inhibitor, in patients with myelofibrosis. Haematologica. 2017 Feb;102(2):327-335. doi: 10.3324/haematol.2016.151126. Epub 2016 Oct 27. PMID 27789678