Phase
Condition
Liver Disorders
Liver Disease
Cancer/tumors
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Cohort A: A histologically or cytologically confirmed diagnosis of advanced solid tumorswhich is either refractory after standard therapy for the disease or for which no effectivestandard therapy is available. Archived tumor tissue available or biopsy of tumor tissueneeds to be performed. Cohort B: A histologically or cytologically confirmed diagnosis of advanced hepatocellularcarcinoma (HCC) which is either refractory after standard therapy for the disease or forwhich no effective standard therapy is available. Archived tumor tissue available or biopsyof tumor tissue needs to be performed. Subjects with Child Pugh A.
Male or female Japanese, age greater than or equal to (>=) 18 years.
Subject has read and understands the informed consent form and is willing and able togive informed consent. The subject fully understands requirements of the trial and iswilling to comply with all trial visits and assessments.
Women of childbearing potential must have a negative blood pregnancy test at thescreening visit.
Female subjects of childbearing potential and male subjects with female partners ofchildbearing potential must be willing to avoid pregnancy by using an adequate methodof contraception for 2 weeks prior to, during and four weeks after the last doseinvestigational medicinal product (IMP).
Life expectancy of at least 3 months
Exclusion
Exclusion Criteria: Hematological abnormality Cohort A: Hematological test abnormalities of Hemoglobin < 9.0g/dL, Neutrophil count < 1.010^9/L and Platelet count < 10010^9/L. Cohort B: Hematological test abnormalities of Hemoglobin < 9.0 g/dL, Neutrophil count < 1.010^9/L, Platelet count < 7510^9/L, subjects with hepatic encephalopathy
Renal impairment as evidenced by serum creatinine > 1.5*upper limit of normal (ULN),and calculated creatinine clearance < 60 mL/min by Cockcroft-Gault formula.
Liver function abnormality of Total Bilirubin > 1.5ULN, or aspartate transaminase 9AST) or alkaline phosphatase (ALT)> 2.5ULN. For subjects with HCC or liverinvolvement AST/ALT > 5*ULN.
History of central nervous system (CNS) metastases, unless subject has been previouslytreated for CNS metastases
History of difficulty swallowing, malabsorption or other chronic gastro-intestinaldisease or conditions
Eastern Cooperative Oncology Group Performance status (ECOG PS) greater than 1.
Has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or anyother anticancer therapy (including any investigational agent) or surgicalintervention within 28 days or 5 half lives for non-cytotoxics of registration.
Baseline corrected QT interval on screening ECG (QTc) >= 480 ms or left ventricularejection fraction (LVEF) < 40% on screening echocardiogram
Cohort B: Subjects with hepatic encephalopathy, remarkable ascites and subjects withhistory of esophageal varices rupture within 6 months (subjects with symptomimprovement after treatment are eligible)
Other serious illness or medical conditions.
Retinal degenerative disease.
Previous treatment with MEK inhibitors.
Legal incapacity or limited legal capacity.
Study Design
Connect with a study center
Please contact
Merck Serono Co., Ltd for recruiting locations in,
JapanSite Not Available

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