Safety and efficacy study of INC424 in patients with myelofibrosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 950

Inclusion Criteria

1. Patients must give written informed consent according to local guidelines prior to any screening procedures; 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 2008 World Health Organization criteria, irrespective of JAK2 mutation status; 5. PMF patients requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen. The prognostic factors, defined by the International Working Group are described in Section 1.1; 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; 7. Patients with a peripheral blood blast count of < 10%; 8. Patients with adequate liver function defined as direct bilirubin = 2.0 x ULN, and ALT = 2.5 x ULN; 9. Patients with adequate renal function defined as serum creatinine = 2 x ULN; 10. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 11. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of study drug; 12. Patients must have recovered or stabilized sufficiently from adverse drug reactions associated with prior treatments before beginning treatment with INC424.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 570

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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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