Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04097821
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    5 mg tablets for oral use
  • Siremadlin — DRUG
    10 mg, 20 mg, or 40 mg capsules for oral use
  • Crizanlizumab — DRUG
    100 mg/10 mL concentrate for infusion for intravenous use
  • Sabatolimab — DRUG
    100 mg/mL or 400 mg/4 mL concentrate for infusion for intravenous use
  • Rineterkib — DRUG
    100 mg capsule for oral use
  • NIS793 — DRUG
    700 mg/7 mL concentrate for infusion for intravenous use

Study Details

The purpose of this study was to investigate the safety, pharmacokinetics and preliminary efficacy of combination treatment of ruxolitinib with 5 novel compounds: siremadlin, crizanlizumab, sabatolimab, rineterkib and NIS793 in myelofibrosis (MF) subjects.

Key Dates

Start date
Sep 26, 2019
Status verified
Jul 2025
Primary completion
May 3, 2023
Completion
Aug 28, 2024

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Ruxolitinib + Siremadlin 20 mg
    Dose escalation of siremadlin added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + Siremadlin 30 mg
    Dose escalation of siremadlin added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + Siremadlin 40 mg
    Dose escalation of siremadlin added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + Rineterkib 200 mg
    Dose escalation of rineterkib added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + Crizanlizumab
    Safety run-in of crizanlizumab added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + Sabatolimab
    Safety run-in of sabatolimab added to existing stable dose of ruxolitinib
  • Experimental: Part 1: Ruxolitinib + NIS793
    Safety run-in of NIS793 added to existing stable dose of ruxolitinib
  • Active Comparator: Part 2: Ruxolitinib
    Existing stable dose of ruxolitinib as control for Part 2

Primary Outcome Measure

Incidence and Severity of Dose Limiting Toxicities Within the First 2 Cycles in Part 1 [ Time Frame: Baseline to the end of Cycle 2 (6 or 8 weeks) ]

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