Description:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the
combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
Title
- Brief Title: A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
- Official Title: A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
Clinical Trial IDs
- ORG STUDY ID:
INCB 50465-201
- SECONDARY ID:
Parsaclisib
- NCT ID:
NCT02718300
Conditions
- MPN (Myeloproliferative Neoplasms)
Interventions
Drug | Synonyms | Arms |
---|
Parsaclisib | INCB050465 | Part 1: Ruxolitinib + Parsaclisib |
Parsaclisib | INCB050465 | Part 2: Ruxolitinib + Parsaclisib |
Ruxolitinib | Jakafi® | Part 1: Ruxolitinib + Parsaclisib |
Parsaclisib | INCB050465 | Part 3: Ruxolitinib + Parsaclisib |
Parsaclisib | INCB050465 | Part 4: Ruxolitinib + Parsaclisib |
Purpose
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the
combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1: Ruxolitinib + Parsaclisib | Experimental | Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria. | |
Part 2: Ruxolitinib + Parsaclisib | Experimental | Part 2 will compare 2 doses of parsaclisib . | |
Part 3: Ruxolitinib + Parsaclisib | Experimental | Part 3 will compare 2 different long term dosing strategies. | |
Part 4: Ruxolitinib + Parsaclisib | Experimental | Part 4 will compare 2 different daily dosing strategies. | |
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or
post-essential thrombocythemia myelofibrosis
- Palpable spleen of > 10 cm below the left subcostal margin on physical examination at
the screening visit OR
- Palpable splenomegaly of 5 to 10 cm below left subcostal margin on physical exam AND
active symptoms of MF at the screening visit as demonstrated by presence of 1 symptom
score ≥ 5 or 2 symptom scores ≥ 3 using the Screening Symptom Form
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria:
- Use of experimental drug therapy for myelofibrosis, or any other standard drug (eg,
danazol, hydroxyurea, etc) with the exception of ruxolitinib within 6 months of
starting study (combination) therapy and/or lack of recovery from all toxicities from
previous therapy (except ruxolitinib) to Grade 1 or better
- Inability to swallow food or any condition of the upper gastrointestinal tract that
precludes administration of oral medications
- Unwillingness to be transfused with blood components
- Recent history of inadequate bone marrow reserve as demonstrated by the following:
- Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet
transfusion(s) within 8 weeks before screening
- Absolute neutrophil count levels < 0.5 × 10^9/L in the 4 weeks before screening
- Subjects with peripheral blood blast count of > 10% at the screening or baseline
hematology assessments
- Subjects who are not willing to receive red blood cell (RBC) transfusions to
treat low hemoglobin levels
- Inadequate liver function at screening as demonstrated by the following:
- Direct bilirubin ≥ 2.0 × the upper limit of laboratory normal (ULN). (NOTE:
direct bilirubin will only be determined if total bilirubin is ≥ 2.0 × ULN)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN
- Inadequate renal function at screening as demonstrated by creatinine clearance < 50
mL/min or glomerular filtration rate < 50 mL/min/1.73 m^2
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
Time Frame: | Baseline to Day 28 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of subjects with adverse events (AEs) and changes in vital signs, ECGs, and laboratory parameters |
Time Frame: | Screening through up to 30 days after last dose of study drug, up to 25 months |
Safety Issue: | |
Description: | |
Measure: | Change in total symptom score as measured by patient-reported myelofibrosis symptoms |
Time Frame: | Baseline through Week 12 or Week 24 |
Safety Issue: | |
Description: | |
Measure: | Change From Baseline in Spleen Volume at Week 24 as measured by MRI or CT scan |
Time Frame: | Baseline to Week 24 |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Primary myelofibrosis (PMF)
- post-polycythemia vera myelofibrosis (PPV-MF)
- post-essential thrombocythemia myelofibrosis (PET-MF)
- myeloproliferative neoplasms (MPNs)
- phosphoinositide 3-kinase (PI3K) inhibitor
- Janus kinase (JAK) inhibitor
Last Updated
March 24, 2021