A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis
- Conditions
- myelofibrosisMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-003415-98-HU
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 212
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. Treated with ruxolitinib for = 3 months with a stable dose for at least the last 8 weeks prior to Day 1;
5. Evidence of suboptimal response to ruxolitinib
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 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136
1. Prior therapy with any drug that inhibits PI3K;
2. Use of experimental drug therapy for MF or any other standard drug used for MF (e.g., danazol, hydroxyurea) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
3. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
4. Recent history of inadequate bone marrow reserve.
For the complete list of exclusion criteria please refer to the protocol, section 5.2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate and compare the efficacy of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on spleen volume at Week 24.;Secondary Objective: * To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib on participant reports of MF symptoms.<br><br>* To evaluate and compare the effect of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib with respect to OS.<br><br>* To evaluate and compare the safety and tolerability of parsaclisib plus ruxolitinib versus placebo plus ruxolitinib;Primary end point(s): Proportion of participants achieving = 25% 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
- Secondary Outcome Measures
Name Time Method 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<br><br>* Change in TSS from baseline to Week 24 as measured by the MFSAF v4.0 diary.<br><br>* Time to the first = 50% reduction in TSS as measured by the MFSAF v4.0 diary<br><br>* OS determined from the date of randomization until death due to any cause.<br><br>* Safety and tolerability ;Timepoint(s) of evaluation of this end point: * Proportion of participants with = 50% reduction in TSS: week 24<br><br>* Change in TSS: week 24<br><br>* Time to the first = 50% reduction in TSS:<br><br>* OS: throughout the study<br><br>* Safety and tolerability: throughout the study<br>