Status:
TERMINATED
Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief 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, sabatolima...
Detailed Description
This open-label, multi-center, Phase Ib/II platform study design consisted of 3 parts. Part 1 was a Phase Ib dose escalation and safety run-in for the 5 novel agents in combination with ruxolitinib to...
Eligibility Criteria
Inclusion
- Core treatment phase
- Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016 World Health Organization (WHO) criteria, or diagnosis of post-essential thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis (PPV-MF) according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) 2007 criteria
- Palpable spleen of at least 5 cm from the left costal margin (LCM) to the point of greatest splenic protrusion or enlarged spleen volume of at least 450 cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first dose of study treatment can be accepted).
- Have been treated with ruxolitinib for at least 12 weeks prior to first dose of study treatment
- Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between 5 and 25 mg twice a day (BID)) for ≥ 4 weeks prior to first dose of study treatment
- Extension treatment phase inclusion criteria:
- Signed consent for the extension treatment phase
- ongoing in the core treatment phase
- demonstrates clinical benefit of treatment in core treatment phase per investigator's assessment.
- Core treatment phase
Exclusion
- Not able to understand and to comply with study instructions and requirements.
- Received any investigational agent for the treatment of MF (except ruxolitinib) within 30 days of first dose of study treatment or within 5 half-lives of the study treatment, whichever is greater
- Peripheral blood blasts count of \> 10%.
- has documented severe hypersensitivity reactions/immunogenicity (IG) to a prior biologic product or Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1 year of screening in NIS793, crizanlizumab or sabatolimab arms, or in rineterkib or siremadlin arms within \<=4 weeks of screening or \<=5 half-lives whichever is shorter
- Splenic irradiation within 6 months prior to the first dose of study drug
- Received blood platelet transfusion within 28 days prior to first dose of study treatment.
- Extension treatment phase
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04097821
Start Date
September 26 2019
End Date
August 28 2024
Last Update
August 7 2025
Active Locations (22)
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1
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
2
Novartis Investigative Site
Melbourne, Victoria, Australia, 3000
3
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
4
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9