myelofibrosis MedDRA version: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Incyte Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 years or older; 2. Diagnosis of PMF, PPV-MF, or PET-MF; 3. DIPSS risk category of intermediate-1, intermediate-2, or high; 4. Evidence of need for treatment for MF (both a and b must be satisfied): a. Palpable spleen of = 5 cm below the left costal margin on physical examination at the screening visit b. Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of = 10 using the Screening Symptom Form 5. ECOG performance status score of 0, 1, or 2 For the complete list of inclusion criteria please refer to the protocol, section 5.1 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 158 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 282
Exclusion criteria
Exclusion criteria: 1. Prior use of any JAK inhibitor. 2. Prior therapy with any drug that inhibits PI3K 3. Use of experimental drug therapy for MF or any other standard drug (except hydroxyurea) used for MF or another indication within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to = Grade 1. Hydroxyurea used for MF or another indication must be discontinued 3 weeks prior to starting study drugs (Day 1). 4. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications 5. Recent history of inadequate bone marrow reserve For the complete list of exclusion criteria please refer to the protocol, section 5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: * To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on participant reports of MF symptoms. * To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib with respect to OS. * To evaluate and compare the safety and tolerability of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib.;Primary end point(s): Proportion of participants achieving = 35% reduction in spleen volume from baseline to Week 24 as measured by MRI (or CT scan in applicable participants).;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: To evaluate and compare the efficacy of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on spleen volume at Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Proportion of participants who have a = 50% reduction in TSS from baseline to Week 24 as measured by the MFSAF v4.0 diary. * Change in TSS from baseline to Week 24 as measured by the MFSAF v4.0 diary. * Time to the first = 50% reduction in TSS as measured by the MFSAF v4.0 diary. * OS determined from the date of randomization until death due to any cause. * Safety and tolerability ;Timepoint(s) of evaluation of this end point: * Proportion of participants with = 50% reduction in TSS: week 24 * Change in TSS: week 24 * Time to the first = 50% reduction in TSS: * OS: throughout the study * Safety and tolerability: throughout the study | — |
Countries
Austria, Belgium, China, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed