A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts * 50 x109/L and <100 x109/L (CINC424A2201)

Completed

• Conditions: myelofibrose; myelofibrosis

• Registration Number: NL-OMON39946
• Lead Sponsor: ovartis Pharma BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

* 18 years of age or older
* Diagnosed with Primary Myelofibrosis (MF), Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia-Myelofibrosis irrespective of JAK2 mutation status, guided by the criteria outlined in the 2008 WHO criteria for PMF.
* MF requiring therapy must be classified at least as intermediate risk level 1, as defined by the International Working Group (see protocol page 42 for details).
* Palpable spleen of at least 5 cm.
* Active symptoms of MF (see protocol page 42 for details).
* Baseline PLT count < 100 x 109/L and * 75 x 109/L (first stratum) and PLT count < 75 x 109/L and * 50 x 109/L (second stratum).
* INR and PTT < 1.5 x ULN.
* ECOG performance status 0, 1, 2.

Exclusion Criteria

* Pregnant or nursing women.
* Patients of childbearing potential who are unwilling to take appropriate contraceptive measures.
* Treatment with hematopoietic growth factor receptor agonists for at least 30 days prior to receiving the first dose of study drug.
* Any history of PLT counts <45 x 109/L within 30 days prior to Screening. See protocol page 43 for exceptions.
* Any history or predisposition to clinically significant bleeding, platelet dysfunction and/or bleeding diathesis.
* Treated concurrently with a potent systemic inhibitor or a potent systemic inducer of CYP3A4.
* Life expectancy of less than 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>DLT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety parameters, PK, platelets, cytokines, spleen length, proportion of<br /><br>patients achieving *50% reduction in palpable spleen length at Week 24, Change<br /><br>in spleen length as measured by palpation from Study Day 1 to Week 24.</p><br>