A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis
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| ClinicalTrials.gov Identifier: NCT02718300 |
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Recruitment Status :
Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : March 24, 2021
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| MPN (Myeloproliferative Neoplasms) | Drug: Parsaclisib Drug: Ruxolitinib | Phase 2 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis |
| Actual Study Start Date : | February 8, 2017 |
| Actual Primary Completion Date : | January 14, 2021 |
| Estimated Study Completion Date : | July 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Primary myelofibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: Ruxolitinib + Parsaclisib
Initial cohort dose of parsaclisib added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
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Drug: Parsaclisib
Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
Other Name: INCB050465 Drug: Ruxolitinib The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
Other Name: Jakafi® |
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Experimental: Part 2: Ruxolitinib + Parsaclisib
Part 2 will compare 2 doses of parsaclisib .
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Drug: Parsaclisib
Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
Other Name: INCB050465 Drug: Ruxolitinib The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
Other Name: Jakafi® |
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Experimental: Part 3: Ruxolitinib + Parsaclisib
Part 3 will compare 2 different long term dosing strategies.
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Drug: Ruxolitinib
The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
Other Name: Jakafi® Drug: Parsaclisib 20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
Other Name: INCB050465 |
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Experimental: Part 4: Ruxolitinib + Parsaclisib
Part 4 will compare 2 different daily dosing strategies.
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Drug: Ruxolitinib
The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
Other Name: Jakafi® Drug: Parsaclisib 2 dose strategies will be compared:
Other Name: INCB050465 |
Primary Outcome Measures :
- Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to Day 28 ]
- Part 2, Part 3 and Part 4: Change From Baseline in Spleen Volume at Week 12 as measured by MRI or CT scan [ Time Frame: Baseline to Week 12 ]
Secondary Outcome Measures :
- 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 ]
- Change in total symptom score as measured by patient-reported myelofibrosis symptoms [ Time Frame: Baseline through Week 12 or Week 24 ]
- Change From Baseline in Spleen Volume at Week 24 as measured by MRI or CT scan [ Time Frame: Baseline to Week 24 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718300
Locations
Show 39 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Albert Assad, MD | Incyte Corporation |
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT02718300 |
| Other Study ID Numbers: |
INCB 50465-201 Parsaclisib ( Other Identifier: Incyte Corporation ) |
| First Posted: | March 24, 2016 Key Record Dates |
| Last Update Posted: | March 24, 2021 |
| Last Verified: | March 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Incyte Corporation:
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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 |
Additional relevant MeSH terms:
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Primary Myelofibrosis Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |