This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Oral; Tablet
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to 2 years and 30 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Time frame: Up to 2 years and 30 days
INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma
INCB160058 and the protocol defined standard disease-directed therapy concentration in plasma.
Time frame: Up to Day 57
For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Time frame: Week 12 and 24 and then every 24 weeks up to 2 years
For participants with MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Time frame: Week 12 and Week 24
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The University of Alabama At Birmingham
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Cornell Medical Center
New York, New York, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Sloan Kettering Institute For Cancer Research
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
...and 20 more locations
For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Time frame: Week 12 and 24 and then every 24 weeks up to 2 years
For participants with ET: Response using revised IWG-MRT and ELN response criteria for ET
Defined as the percentage of participants with Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria.
Time frame: Week 12 and 24 and then every 24 weeks up to 2 years
For all participants: Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)
Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.
Time frame: Week 24
For all participants: Symptom improvement in TSS at Weeks 12 and 24 relative to baseline as measured by the Myeloproliferative Neoplasms Symptom Assessment Form (MPN-SAF) TSS.
Defined as the proportion of participants who achieve a protocol defined reduction in Total Symptomatic Score (TSS) relative to baseline as measured by the MPN-SAF TSS.
Time frame: Week 12 and Week 24