A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms
Summary
This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.
Arms & interventions
- DrugINCB160058
Oral; Tablet
- DrugStandard disease-directed therapy
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Outcome measures
Primary
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
Secondary
INCB160058 and a standard disease-directed therapy pharmacokinetic (PK) in Plasma
Time frame: Up to Day 57
For participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
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
Time frame: Week 12 and Week 24
For participants with PV: Response using revised IWG-MRT and ELN response criteria for PV
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
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)
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.
Time frame: Week 12 and Week 24
Eligibility criteria
Study locations (13)
The University of Alabama At Birmingham
Birmingham, Alabama, 35249
Stanford University
Palo Alto, California, 94304
Moffitt Cancer Center
Tampa, Florida, 33612
Northwestern University
Chicago, Illinois, 60611
The University of Kansas Cancer Center Kucc University of Kansas Clinical Research Center
Fairway, Kansas, 66205
University of Michigan
Ann Arbor, Michigan, 48109-5008
Cornell Medical Center
New York, New York, 10021
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
Sloan Kettering Institute For Cancer Research
New York, New York, 10065
Oregon Health & Science University
Portland, Oregon, 97239
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Md Anderson Cancer Center
Houston, Texas, 77030