primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF) or Post essential thrombocythemia myelofibrosis (PET-MF)
Conditions
Interventions
Product Name: ruxolitinib
Product Code: INC424
Pharmaceutical Form: Tablet
INN or Proposed INN: Ruxolitinib INC424
CAS Number: 1092939-17-7
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to collect additional safety of INC424 in patients with PMF, PPV MF, or PET MF, who have either received prior treatment with commercially available agents or never received treatment;Secondary Objective: To document the best overall response rate to INC424 in patients with PMF, PPV MF , or PET MF as evaluated by the investigator To collect quality of life (QoL) endpoints To document medical resource utilization;Primary end point(s): Safety: Clinical and laboratory parameters will be collected to evaluate study drug safety and toxicity. Safety and tolerability will be collected by monitoring the frequency, duration and severity of all grade adverse events (AEs) by CTCAE v.3.0, performing physical exams (PE), and evaluating changes in vital signs (VS), ECOG performance status (PS), ECGs and serum chemistry and hematology results. Grade 3 and 4 AEsm, Serious Adverse Events (SAEs). Frequency of dose interruptions and discontinuations due to AEs. ;Timepoint(s) of evaluation of this end point: Monthly for the first 3 months, then every 3 months and at study discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life: Change in ECOG PS from baseline Change in FACT-Lym Change in Functional Assessment of Chronic Illness Therapy;Timepoint(s) of evaluation of this end point: Monthly for the first 3 months, then every 3 months and at study discontinuation | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, Germany, Greece, Hungary, Ireland, Italy, Korea, Republic of, Lebanon, Mexico, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Venezuela, Bolivarian Republic of
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed