The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

NCT02404584 | Completed

• 2 other identifiers: LOCAL/2014/LM-01bis2014-005534-55
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 3

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).

Conditions

Kidney Neoplasms

Keywords

Metastatic kidney cancer

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml

  \*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.

  Between C1D15* and C1D28*

Secondary Outcomes (20)

• Genotype: genetic polymorphisms of enzymes of phase I, phase II (conjugation), carriers of Phases 0 and III, the nuclear receptors PXR and CAR, pharmacological targets of sunitinib (tyrosine kinase receptors).

  Baseline (day 0)

• [Suni]REq per cure

  Between CmD15* and CmD28* for 18 months

• The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure

  18 months

• Tumor response per cure

  18 months

• Toxicity (yes/no) for each type of toxic event per cure

  Between CmD15* and CmD28* for 18 months

Study Arms (1)

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

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

Interventions

Blood drawn for genotyping GENETIC

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

The study population

Blood drawn for pharmacokinetic measures 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.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of patients with renal cell carcinoma treated with sunitinib (Sutent).

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another interventional study
• The patient has participated in another interventional study within the last month
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (3)

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Institut de Cancérologie du Gard (ICG)

Nîmes, 30029, France

Location

Related Publications (1)

• 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 Sep-Oct;26(13-14):485-493. doi: 10.1080/14622416.2025.2579001. Epub 2025 Nov 24.

  PMID: 41277563 RESULT

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Genotype

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Litaty Mbatchi, PharmD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: December 29, 2015
• Primary Completion: May 21, 2019
• Study Completion: May 21, 2019
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (3)