The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer — GenCInibs-Suni  

Kidney Neoplasms Clinical Trial

Official title: The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants

Status Completed

Clinical Trial Summary

The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml (effective concentration according to the current literature).

Clinical Trial Description

The secondary objectives of this study are:

• To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with

• the [Suni]REq,

• the advent of toxicity,

• the tumor response.

• To describe the variation in the [Suni]REq and the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq) at:

• the interindividual level,

• overtime, between chemotherapy cycles.

• To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) to the [Suni]REq at:

• the interindividual level,

• overtime, between chemotherapy cycles.

• To explore potential correlations between the [Suni]REq and

• toxicity,

• tumor response.

• To explore potential correlations between the [ActEnt]REq and

• toxicity,

• tumor response.

• To explore potential correlations between the ratio [Metab]REq / [Suni]REq and

• toxicity,

• tumor response. ;

Related Conditions & MeSH terms

• Kidney Neoplasms

• NCT number: NCT02404584
• Study type: Observational
• Source: Centre Hospitalier Universitaire de Nimes
• Status: Completed
• Start date: December 29, 2015
• Completion date: May 21, 2019