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 …

In the past, patients with cancer, who also have hepatic or renal dysfunction, have carried a
triple burden. Not only have they suffered from cancer and organ dysfunction, but until …

2567 Background: Liver impairment confounds dosing of anti-neoplastic agents. The Cancer
Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI) sponsors …

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 …

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 …

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 …

Since the inception of Phase I clinical trials in cancer, patients with renal dysfunction have
commonly been excluded from participation because of a poor outlook. Most cancer drugs …

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 …

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

Cancer patients with adequate hepatic or renal function are typically studied in clinical trials.
Since most anticancer agents are cleared via hepatic or renal mechanisms, dose …