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

28 gennaio 2020 aggiornato da: Centre Hospitalier Universitaire de Nīmes

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

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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

43

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Montpellier cedex 5, Francia, 34295
        • CHRU de Montpellier - Hôpital Saint-Eloi
      • Nîmes Cedex 09, Francia, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau
      • Nîmes Cedex 9, Francia, 30029
        • Institut de Cancérologie du Gard (ICG)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Genetico: Blood drawn for genotyping
Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
Lasso di tempo: 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.
Between C1D15* and C1D28*

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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).
Lasso di tempo: 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
Baseline (day 0)
[Suni]REq per cure
Lasso di tempo: 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.
Between CmD15* and CmD28* for 18 months
The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure
Lasso di tempo: 18 months
18 months
Tumor response per cure
Lasso di tempo: 18 months
18 months
Toxicity (yes/no) for each type of toxic event per cure
Lasso di tempo: 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.
Between CmD15* and CmD28* for 18 months
[Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)
Lasso di tempo: 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.
Between C1D15* and C1D28*
the average [Suni]REq over all cures
Lasso di tempo: 18 months
18 months
For each cure, the average [Suni]REq for cure 1 to cure m
Lasso di tempo: 18 months
18 months
For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq
Lasso di tempo: 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.
Between CmD15* and CmD28* for 18 months
[Metab]REq / [Suni]REq
Lasso di tempo: 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.
Between C1D15* and C1D28*
[Metab]REq / [Suni]REq averaged per initial dosing
Lasso di tempo: 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.
Between C1D15* and C1D28*
Mean [Metab]REq / [Suni]REq for all cures
Lasso di tempo: 18 months
18 months
For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m
Lasso di tempo: 18 months
18 months
For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)
Lasso di tempo: 18 months
18 months
[ActEnt]REq
Lasso di tempo: 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.
Between C1D15* and C1D28*
[ActEnt]REq averaged per initial dosing
Lasso di tempo: 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.
Between C1D15* and C1D28*
Mean [ActEnt]REq for all cures
Lasso di tempo: 18 months
18 months
For each cure, the average [ActEnt]REq for cure 1 to cure m
Lasso di tempo: 18 months
18 months
For each cure, the % of patients whose dosings were modified since the beginning of the study
Lasso di tempo: 18 months
18 months
Presence/absence of side effects noted in the summary of product characteristics for sunitinib
Lasso di tempo: 18 months
18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigatori

  • Direttore dello studio: Litaty Mbatchi, PharmD, Centre Hospitalier Universitaire De Nimes

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 dicembre 2015

Completamento primario (Effettivo)

21 maggio 2019

Completamento dello studio (Effettivo)

21 maggio 2019

Date di iscrizione allo studio

Primo inviato

26 marzo 2015

Primo inviato che soddisfa i criteri di controllo qualità

30 marzo 2015

Primo Inserito (Stima)

31 marzo 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 gennaio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 gennaio 2020

Ultimo verificato

1 gennaio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LOCAL/2014/LM-01bis
  • 2014-005534-55 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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