Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
NCT04097821 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-08-07
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
-
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
- lead INDUSTRY
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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