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 …

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 …

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 …

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 …

The FDA guidance for industry in the premarketing clinical evaluation of drug-induced liver
injury (DILI) is the most specific regulatory guidance currently available and has been useful …

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 …

6051 Background: Patients with HD may require drug dose modification based on the
severity of HD. HD is often assessed using CP criteria, the use of which is advocated by the …

Methods: We conducted a retrospective review of 284 patients who underwent
chemotherapy for prostate, bladder, testicular and renal cell carcinomas over a two year …

Background Data on drug‐induced liver injury (DILI) and acute liver failure (ALF) in modern
phase 1 oncology trials are limited, specifically with respect to the incidence and resolution …