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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Kidney Neoplasms

Treatments: Biological: Blood drawn for pharmacokinetic measures; Genetic: Blood drawn for genotyping

Study type: Observational

Funder types: Other

Identifiers

NCT02404584

LOCAL/2014/LM-01bis

2014-005534-55 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient was correctly informed concerning the implementation of the study, its objectives, constraints and patient rights
• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient has kidney cancer and should begin treatment with sunitinib (Sutent) at the time of inclusion

Exclusion criteria

• The patient started treatment with sunitinib (Sutent) before inclusion
• The patient is participating in another interventional study
• The patient has participated in another interventional study within the last month
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• The patient has a contraindication (or an incompatible drug combination) for a treatment used in this study

Trial design

43 participants in 1 patient group

The study population

Description:

Patients with kidney cancer and will be starting treatment via sunitinib at the study start will be included. Intervention: Blood drawn for genotyping Intervention: Blood drawn for pharmacokinetic measures

Treatment:

Genetic: Blood drawn for genotyping

Biological: Blood drawn for pharmacokinetic measures