Purpose The liver is critically involved in drug metabolism pathways and the potential for
hepatic toxicity is significant with specific cancer therapeutics. Variations in the definition of …

Guidance from the US Food and Drug Administration (FDA) and the European Medicines
Agency recommends using Child‐Pugh classification for pharmacokinetic evaluation in …

The liver is a vital organ that plays a central role in the metabolism and elimination of drug
molecules. Impairment of this vital organ can lead to increased accumulation of parent drug …

Introduction The goal of organ dysfunction Phase I trials is to characterize the safety and
pharmacokinetics of novel agents in cancer patients with liver or kidney dysfunction, but the …

Introduction: We conducted a systematic literature review to assess the utility of liver function
assessments for predicting disease prognosis and response to systemic anticancer therapy …

Design and execution of clinical trials use definitions and criteria to permit a homogeneous
study development avoiding heterogeneous decisions by investigators at different sites …

Abstract Purpose: The NCI Cancer Therapy Evaluation Program sponsors hepatic
dysfunction phase I clinical trials (HDCT) and phase 1 clinical trials (P1CT) to determine safe …

Patients with cancer and advanced hepatic impairment (HI)(ie, moderate and severe
impairment) are often excluded from first‐in‐patient, phase II, and phase III studies. Thus …

The liver is fundamentally important in drug metabolism. In oncology, the astute clinician
must not only understand the meaning and limitations of commonly ordered liver …

Background Management of side effects in clinical trials has to balance generation of
meaningful data with risk for patients. A toxicity area requiring detailed management …