Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

NCT04097821 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-08-07

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ruxolitinib

5 mg tablets for oral use

DRUG

Siremadlin

10 mg, 20 mg, or 40 mg capsules for oral use

DRUG

Crizanlizumab

100 mg/10 mL concentrate for infusion for intravenous use

DRUG

Sabatolimab

100 mg/mL or 400 mg/4 mL concentrate for infusion for intravenous use

DRUG

Rineterkib

100 mg capsule for oral use

DRUG

NIS793

700 mg/7 mL concentrate for infusion for intravenous use

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2023-05-03
Completion
2024-08-28

Countries

  • Australia
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097821 on ClinicalTrials.gov