The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

NCT ID: NCT02404584

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-29
• Study Completion Date: 2019-05-21

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The study population

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

Blood drawn for genotyping

Intervention Type: GENETIC

Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).

Blood drawn for pharmacokinetic measures

Intervention Type: BIOLOGICAL

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.

Interventions

Blood drawn for genotyping

Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).

Intervention Type: GENETIC

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Litaty Mbatchi, PharmD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Institut de Cancérologie du Gard (ICG)

Nîmes, , France

Countries

France

References

Mbatchi LC, Leenhardt F, Occean BV, Perrin O, Boyer JC, Gongora C, Pourquier P, Mura T, Chapelle A, Topart D, Evrard A, Houede N. Genetic polymorphisms of VEGFR2 and FGFR2 genes are associated with exposure to sunitinib and cardiovascular toxicity. Pharmacogenomics. 2025 Nov 24:1-9. doi: 10.1080/14622416.2025.2579001. Online ahead of print.

Reference Type: RESULT

PMID: 41277563 (View on PubMed)

Other Identifiers

2014-005534-55

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2014/LM-01bis

Identifier Type: -

Identifier Source: org_study_id