Myelodysplastic Syndrome Clinical Trial

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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:

•MF

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).

MDS

Very low-, low-, intermediate-, or high risk MDS as per the IPSS-R criteria

MDS/MPN

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.

Exclusion Criteria:

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT04279847

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 26 Locations for this study

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University of Alabama At Birmingham
Birmingham Alabama, 35294, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Emory University-Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of North Carolina At Chapel Hill
Chapel Hill North Carolina, 27514, United States
University of Cincinnati Cancer Institute
Cincinnati Ohio, 45267, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute At University of Utah
Salt Lake City Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
St Paul'S Hospital
Vancouver British Columbia, V6E 1, Canada
Princess Margaret Cancer Center
Toronto Ontario, MG5 2, Canada
Helsinki University Central Hospital
Helsinki , 00029, Finland
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna , 40138, Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Firenze , 50134, Italy
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan , 20122, Italy
Fujita Health University Hospital
Aichi , 470-1, Japan
Chiba University Hospital
Chiba , 260-8, Japan
National Cancer Center Hospital East
Chiba , 277-8, Japan
Kyushu University Hospital
Fukuoka , , Japan
Ico Hospital Germans Trias I Pujol
Badalona , 08916, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas , 35019, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen de La Arrixaca
Murcia , 30120, Spain
Hospital Clinico Universitario de Salamanca
Salamanca , 37007, Spain
United Lincolnshire Hospitals
Boston , PE21 , United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester , M20 4, United Kingdom
University of Oxford
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT04279847

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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