Clinical Trials /

A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

NCT02718300

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.

Related Conditions:
  • Myelofibrosis Transformation in Essential Thrombocythemia
  • Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
  • Primary Myelofibrosis
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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
  • NCT ID: NCT02718300

Conditions

  • Myelofibrosis

Interventions

DrugSynonymsArms
INCB050465Part 1: Ruxolitinib + INCB050465
INCB050465Part 2: Ruxolitinib + INCB050465
RuxolitinibJakafi®Part 1: Ruxolitinib + INCB050465

Purpose

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of INCB050465 and ruxolitinib in subjects with myelofibrosis.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Ruxolitinib + INCB050465ExperimentalInitial cohort dose of INCB050465 added to existing stable regimen of ruxolitinib, with subsequent cohort escalations based on protocol-specific criteria.
  • INCB050465
  • Ruxolitinib
Part 2: Ruxolitinib + INCB050465ExperimentalPart 2 will compare 2 doses of INCB050465
  • INCB050465
  • Ruxolitinib

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 and baseline visits 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 and baseline visits 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: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

April 19, 2017