A Randomized Study of the JAK Inhibitor INCB018424 Tablets Compared to Best Available Therapy in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) - COMFORT II

• Conditions: MedDRA version: 12.0Level: LLTClassification code 10028537Term: Myelofibrosis; Myelofibrosis

• Registration Number: EUCTR2009-009858-24-IT
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-02
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Male or female subjects, aged 18 years or older, with diagnosis of PMF, PPV-MF or PET-MF. Subjects with a palpable spleen length of 5 cm or greater below the costal margin Subjects must have either 2 (Intermediate risk) or 3 or more (High risk) prognostic factors (Cervantes et al, 2008). These prognostic factors are: a) Age > 65 yrs b) Presence of constitutional symptoms (weight loss, fever, night sweats) c) Marked anemia (Hgb < 10g/dL) d) Leukocytosis (history of WBC > 25 x 109/L) e) Circulating blasts &#8805; 1% Subjects with peripheral blood blasts of < 10% Subjects must have been on a stable therapeutic regimen for at least 2 weeks before Screening and at least 4 weeks prior to Baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with a life expectancy of < 6 months. Subjects with inadequate bone marrow reserve as follows: a) Absolute neutrophil count (ANC) that is &#8804; 1000/?L. b) Platelet count that is < 100,000/?L without the assistance of growth factors, thrombopoietic factors or platelet transfusions. Subjects with any history of platelet counts < 50,000/?L or ANC < 500/?L except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason. Subjects having clinically significant infections or current malignancies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: o To compare the efficacy, safety and tolerability of INCB018424 given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).;Secondary Objective: o To evaluate the population pharmacokinetics of INCB018424;Primary end point(s): o Proportion of subjects achieving at least 35% reduction in spleen volume from Baseline to Week 48 as measured by MRI (or by CT for applicable subjects).