primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV MF)and post essential thrombocythemia vera (PETMF) MedDRA version: 16.1 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Jakavi
Product Name: INC424 5 mg
Product Code: INC424
Pharmaceutical Form: Tablet
INN or Proposed INN: ruxolitinib
CAS Number: 1092939-17-7
Current Sponsor code: INC424
Other descriptive n
Sponsors
Novartis Farmacéutica, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria 2. Peripheral blast count =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Patients not initially responding (primary resistance) to ruxolitinib therapy 2. Patients who underwent a splenectomy or spleen radiation 3. Patients currently scheduled for bone marrow transplant 4. Patients who have discontinued ruxolitinib < 14 days prior to screening 5. Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose 6. Leukemic transformation 7. Inadequate renal function 8. Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy 9. Previous history of Progressive Multifocal Leuko-encephalopathy (PML) 10. Clinically significant cardiac disease or significant concurrent medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 20% from baseline, by Week 24;Secondary Objective: 1. To evaluate the effect of re-treatment with ruxolitinib on reduction in spleen volume of at least 35% from baseline, by Week 24 2. To evaluate the effect of re-treatment with ruxolitinib on reduction in spleen length of at least 25% and 50% respectively, from baseline, by Week 24 3. To evaluate the effect of re-treatment with ruxolitinib on reduction in spleen volume and length over time 4. To evaluate the safety after re-treatment with ruxolitinib 5. To evaluate the effect of re-treatment with ruxolitinib on reduction in MPNSAF TSS of at least 25% and 50% respectively, from baseline, by Week 24 6. To evaluate the effect of re-treatment with ruxolitinib on reduction in MPNSAF TSS over time 7. To evaluate the effect of re-treatment with ruxolitinib on Patient Global Impression of Change (PGIC) 8. To evaluate the effect of re-treatment with ruxolitinib on EORTC QLQ-C30 and EQ-5D-5L;Primary end point(s): Proportion of patients achieving ?20% reduction from baseline in spleen volume by Week 24 after re-treatment with ruxolitinib;Timepoint(s) of evaluation of this end point: By week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. By Week 24 2. By Week 24 3. Each visit 4. Each visit 5. By Week 24 6. Each visit 7. Each visit measured 8. Each visit measured;Secondary end point(s): 1. Proportion of patients achieving greater than or equal to 35% reduction from baseline in spleen volume by Week 24 after re-treatment with ruxolitinib 2. Proportion of patients achieving greater than or equal to 25% and 50% reduction respectively, from baseline, in spleen length by Week 24 after re-treatment with ruxolitinib 3. Change in spleen length as well as in spleen volume from baseline to each visit where measured after re-treatment with ruxolitinib 4. Safety will be assessed by monitoring the frequency, duration and severity of Adverse Events, and evaluating changes in vital signs, electrocardiograms (ECGs), serum chemistry, hematology and urinalysis results 5. Proportion of patients achieving greater than or equal to 25% and 50% reduction respectively, from baseline in total symptom score (MPN-SAF TSS) by Week 24 after re-treatment with ruxolitinib 6. Change in MPN-SAF TSS from baseline to each visit where measured after re-treatment with ruxolitinib 7. PGIC at each visit where measured after retreatment with ruxolitinib 8. Change in EORTC QLQ-C30 and EQ-5D-5L scores from baseline to each visit where measured after re-treatment with ruxolitinib | — |
Countries
Austria, Brazil, Canada, China, France, Germany, Greece, Italy, Spain, Thailand, United Kingdom
Contacts
Public ContactDepartamento Médico Oncología (GMO)
Novartis Farmacéutica, S.A.
Outcome results
None listed