Safety and efficacy study of INC424 in patients with myelofibrosis

Phase 1

• Conditions: primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF) or Post essential thrombocythemia myelofibrosis (PET-MF); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024473-39-IE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. patient must give written informed consent according to local guideliens prior to any screening procedure
2. patients must not be eligible for another ongoing INC424 clinical trial
3. male or female patients aged >18 years of age
4. patients must be diagnosed with PMF, PPv mf or PET MF according to the WHO citeria 2008
5. PMF patients requiruing therapy must be classified as high risk or intermediate risk level 2 or intermediate risk level 1 with enlarged spleen
6. patients with intermediate-1 and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients eligible for hematopoietic stem cell transplantation
2. Patients with a history of malignancy in the past 3 years, except for treated early stage squamous or basal cell carcinoma in situ
3. patients undergoing treatment with hematopoietic growth factor receptor agonists, granulocyte colony stimulant factor at nay time within 2 weeks prior to screening or 4 weeks prior to baseline
4. Patients currently participating in COMFORT-I and COMFORT -II trials
5.Patients receiving any medications listed in the prohibited medications listing
6. Impairment of GI function or GI disease that may alter the absorption of INC424
7. Patients with cardiac disease which my jeopardize the safety of the patient
8. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal fibrillation or recent myocardial infarction or acute coronary syndrome
9. Patients with clinically significant infections (for further details see protocol)
10. Patients with known active hepatitis a, B, C or who are HIV -positive
11. Patients with coagulation parameters
12.Pregnant or nursing women

Study & Design

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