Phase
Condition
Neoplasms
Liver Disease
Liver Failure
Treatment
Onureg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acutepromyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negativemyeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasmsoverlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blasticplasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification
Life expectancy of ≥ 3 months
Stable renal function without dialysis for at least 2 months prior toinvestigational product administration
Has moderate or severe hepatic impairment as defined by National Cancer InstituteOrgan Dysfunction Working Group criteria
Exclusion
Exclusion Criteria:
Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer,prior to the first day of investigational product administration
Persistent, clinically significant non-hematologic toxicities from prior therapieswhich have not recovered to < Grade 2
Any condition including the presence of laboratory abnormalities, which places theparticipant at unacceptable risk if he/she were to participate in the study
History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastricbypass, upper bowel removal, or any other gastrointestinal disorder or defect thatwould interfere with the absorption of the investigational product and/or predisposethe participant to an increased risk of gastrointestinal toxicity
Other protocol-defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Hospital Universitario Austral
Pilar, Buenos Aires 1629
ArgentinaActive - Recruiting
Local Institution - 0011
Pilar, Buenos Aires 1629
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
ABB, Ciudad Autónoma De Buenos Aires C1199ABB
ArgentinaActive - Recruiting
Local Institution - 0010
ABB, Ciudad Autónoma De Buenos Aires C1199ABB
ArgentinaSite Not Available
Hospital Aleman
Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
ArgentinaActive - Recruiting
Local Institution - 0014
Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
ArgentinaSite Not Available
Clínica Zabala
Buenos Aires, 1426
ArgentinaActive - Recruiting
Local Institution - 0012
Buenos Aires, 1426
ArgentinaSite Not Available
Instituto Nacional De Cancerologia
Bogota, Cundinamarca 111151
ColombiaActive - Recruiting
Local Institution - 0084
Bogota, Cundinamarca 111151
ColombiaSite Not Available
Fundacion Ctic Centro de Tratamiento E Investigacion Sobre Cancer Luis Carlos Sarmiento Angulo
Bogotá, Distrito Capital De Bogotá 110131
ColombiaActive - Recruiting
Local Institution - 0085
Bogotá, Distrito Capital De Bogotá 110131
ColombiaSite Not Available
Local Institution - 0086
Floridablanca, Santander 681004
ColombiaSite Not Available
Fundación Cardiovascular de Colombia
Piedecuesta, Santander 681017
ColombiaActive - Recruiting
Local Institution - 0086
Piedecuesta, Santander 681017
ColombiaSite Not Available
Klinikum Augsburg
Augsburg, Bayern 86156
GermanyActive - Recruiting
Local Institution - 0076
Augsburg, Bayern 86156
GermanySite Not Available
Local Institution - 0075
Halle, Sachsen-Anhalt 06120
GermanyActive - Recruiting
Local Institution - 0074
Hamburg, 20246
GermanyActive - Recruiting
Local Institution - 9000
Thessaloniki, 54622
GreeceSite Not Available
Local Institution - 0018
Badalona, Barcelona [Barcelona] 08916
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Local Institution - 0017
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Clinica Universidad de Navarra
Pamplona, Navarra 31008
SpainActive - Recruiting
Local Institution - 0015
Pamplona, Navarra 31008
SpainSite Not Available
Local Institution - 0078
Salamanca, 37007
SpainActive - Recruiting
Local Institution - 0083
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
Tulane Cancer Center
New Orleans, Louisiana 70112
United StatesSite Not Available
Local Institution - 0068
Worcester, Massachusetts 01655
United StatesSite Not Available
University of Massachusetts Chan Medical School
Worcester, Massachusetts 01655
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Local Institution
Port Jefferson Station, New York 11776
United StatesSite Not Available
Local Institution - 0007
Port Jefferson Station, New York 11776
United StatesSite Not Available
Local Institution
Cleveland, Ohio 44106
United StatesSite Not Available
Local Institution - 9003
Charlottesville, Virginia 22903
United StatesSite Not Available
University of Virginia Cancer Center
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesSite Not Available
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