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Completed

NCT Number: NCT02404584

The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Saint-Eloi, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood drawn for genotyping

Genetic

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

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.

Primary outcomes

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

    Time frame: Between C1D15* and C1D28*

    *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.

Secondary outcomes

  1. 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).

    Time frame: Baseline (day 0)

    Predefined list of genes:

    ABCB1 ABCC2 ABCG2 CYP1A1 CYP1A2 CYP2A6 CYP2B6 CYP2C19 CYP2C8 CYP2C9 CYP2D6 CYP2E1 CYP3A4 CYP3A5 NR1I2 NR1I3 SLC15A2 SLC22A1 SLC22A2 SLC22A6 SLCO1B1 SLCO1B3 SULT1A1 UGT1A1 UGT2B15 UGT2B17 UGT2B7 VEGFR1,2,3 PDGFR-α et β KIT

  2. [Suni]REq per cure

    Time frame: Between CmD15* and CmD28* for 18 months

    *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.

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

    Time frame: 18 months

  4. Tumor response per cure

    Time frame: 18 months

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

    Time frame: Between CmD15* and CmD28* for 18 months

    *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.

  6. [Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)

    Time frame: Between C1D15* and C1D28*

    *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.

  7. the average [Suni]REq over all cures

    Time frame: 18 months

  8. For each cure, the average [Suni]REq for cure 1 to cure m

    Time frame: 18 months

  9. For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq

    Time frame: Between CmD15* and CmD28* for 18 months

    *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.

  10. [Metab]REq / [Suni]REq

    Time frame: Between C1D15* and C1D28*

    *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.

  11. [Metab]REq / [Suni]REq averaged per initial dosing

    Time frame: Between C1D15* and C1D28*

    *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.

  12. Mean [Metab]REq / [Suni]REq for all cures

    Time frame: 18 months

  13. For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m

    Time frame: 18 months

  14. For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)

    Time frame: 18 months

  15. [ActEnt]REq

    Time frame: Between C1D15* and C1D28*

    *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.

  16. [ActEnt]REq averaged per initial dosing

    Time frame: Between C1D15* and C1D28*

    *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.

  17. Mean [ActEnt]REq for all cures

    Time frame: 18 months

  18. For each cure, the average [ActEnt]REq for cure 1 to cure m

    Time frame: 18 months

  19. For each cure, the % of patients whose dosings were modified since the beginning of the study

    Time frame: 18 months

  20. Presence/absence of side effects noted in the summary of product characteristics for sunitinib

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: GenCInibs-Suni

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 31, 2015
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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