NCT02404584

The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Kidney Neoplasms

Interventions

Type	Name	Description
GENETIC	Blood drawn for genotyping	Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
BIOLOGICAL	Blood drawn for pharmacokinetic measures	Blood will be drawn for pharmacokinetic measures between CmD15 and CmD28 of each sunitinib cycle.\* \*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal). Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order. Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.

Timeline

• Start date: 2015-12-29
• Primary completion: 2019-05-21
• Completion: 2019-05-21
• First posted: 2015-03-31
• Last updated: 2025-12-04

Locations

3 sites across 1 country: France