An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects with Advanced Malignancies and Varying Degrees of Hepatic Impairment - CFZ002

Onyx Therapeutics, Inc.0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月29日

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•1. Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies);2. At least 2 prior treatment regimens for the underlying malignancy;3. Histologically or cytologically confirmed advanced solid tumor or hematologic malignancy;4. Measurable or evaluable disease;5. Clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. Hepatic impairment will be assessed as per NCI-ODWG schema and will fall into one of the following three categories:;- Cohort 2 (mild): Bilirubin > 1*1.5 × upper limit of the normal range (ULN) or aspartate aminotransferase (AST) > ULN, but bilirubin * ULN;- Cohort 3 (moderate): * 1.5*3 × ULN; any AST;- Cohort 4 (severe): Bilirubin > 3 × ULN; any AST;Exception to Inclusion Criterion #5 for Subjects with Normal Hepatic Function:;All subjects enrolled with normal hepatic function (N<=10) must meet all inclusion criteria as outlined with the exception of Inclusion Criterion #5, which should be substituted with the following criterion to be enrolled into the study: ;- Cohort 1 (normal hepatic function): Bilirubin * ULN; AST * ULN ;6. ECOG Performance Status 0-2;7. Left ventricular ejection fraction (LVEF) * 40 within 21 days prior to enrollment;8. Adequate renal function (calculated creatinine clearance *30mL/min)

•1. Subjects with symptomatic brain metastasis or central nervous system [CNS] disease;2. Significant neurotoxicity (Grade 2 with pain or higher) at the time of enrolment;3. Known HIV, Hepatitis B virus and Hepatitis C virus infection (Exception: Subjects with chronic or cleared HBV and HCV infection and stable liver function tests [bilirubin, AST] will be allowed)

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