Myelodysplastic Syndrome Clinical Trial
Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis and other myeloid neoplasms.
Age 18 years and older at the time of signing the informed consent.
Part 1: Relapsed or refractory MF, MDS, or MDS/MPN
a. Disease type:
Primary MF or secondary MFs (post-PV MF, post-ET MF), histologically or cytologically confirmed according to WHO 2016 criteria with measurable disease and risk category of intermediate-2 or high according to DIPSS.
Measurable disease is defined:
For dose escalation as having a palpable spleen of ≥ 5 cm below the left subcostal margin (ribs).
Very low-, low-, intermediate-, or high risk MDS as per the IPSS-R criteria
Low-, intermediate-, or high-risk chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, MDS/MPN with ring sideroblasts and thrombocytosis, and MDS/MPN unclassifiable as per the WHO 2016 criteria.
Exception: Participants presenting with juvenile myelomonocytic leukemia will be excluded.
b. Prior therapy
Received at least 1 line of prior therapy; is refractory, relapsed, or intolerant to the last therapy; and there is no further available therapy known to provide clinical benefits, in the opinion of the investigator.
Participants with MF must have received a JAK inhibitor(s) such as ruxolitinib.
Part 2: MF - dose escalation and expansion
a. Disease type
Primary MF or secondary MFs (post-PV MF, post-ET MF), histologically or cytologically confirmed according to WHO 2016 criteria.
Measurable disease is defined as having a palpable spleen of > 10 cm below the left subcostal margin.
2 subgroups of participants in Part 2 - dose expansion will be enrolled:
bone marrow myeloblast percentage between 5% (≥ 5%) and less than 20% (< 20%) or myeloblast percentage ≥ 10% in peripheral blood in 2 occasions at least 2 weeks apart.
b. Prior therapy
Must currently be treated with ruxolitinib monotherapy at a stable dose for ≥ 8 weeks immediately preceding the first dose of study treatment.
Must not be a candidate for potentially curative therapy, including hematopoietic stem-cell transplantation.
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate at screening/baseline, or archival sample obtained since completion of most recent therapy.
Willingness to avoid pregnancy or fathering children based on the criteria below.
Prior receipt of a BET inhibitor within 5 half-lives of the compound, and/or experienced BET inhibitor-related AE(s) resulting in dose discontinuation.
Note: For participants in Part 2, ruxolitinib will continue at the participants' current, ongoing doses. No ruxolitinib washout is needed.
Concurrent anticancer therapy
Participants who have received allogeneic hematopoietic stem cell transplantation within 6 months of enrollment
Active HBV or HCV infection or at risk for HBV reactivation.
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There are 26 Locations for this study
Birmingham Alabama, 35294, United States
Aurora Colorado, 80045, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
Chapel Hill North Carolina, 27514, United States
Cincinnati Ohio, 45267, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Vancouver British Columbia, V6E 1, Canada
Toronto Ontario, MG5 2, Canada
Helsinki , 00029, Finland
Bologna , 40138, Italy
Firenze , 50134, Italy
Milan , 20122, Italy
Aichi , 470-1, Japan
Chiba , 260-8, Japan
Chiba , 277-8, Japan
Fukuoka , , Japan
Badalona , 08916, Spain
Las Palmas , 35019, Spain
Madrid , 28041, Spain
Murcia , 30120, Spain
Salamanca , 37007, Spain
Boston , PE21 , United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
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