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

28 januari 2020 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

43

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Genetisk: Blood drawn for genotyping
Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
Biologisk: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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).
Tidsram: 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
Tidsram: 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
Tidsram: 18 months
18 months
Tumor response per cure
Tidsram: 18 months
18 months
Toxicity (yes/no) for each type of toxic event per cure
Tidsram: 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)
Tidsram: 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
Tidsram: 18 months
18 months
For each cure, the average [Suni]REq for cure 1 to cure m
Tidsram: 18 months
18 months
For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 18 months
18 months
For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m
Tidsram: 18 months
18 months
For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)
Tidsram: 18 months
18 months
[ActEnt]REq
Tidsram: 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
Tidsram: 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
Tidsram: 18 months
18 months
For each cure, the average [ActEnt]REq for cure 1 to cure m
Tidsram: 18 months
18 months
For each cure, the % of patients whose dosings were modified since the beginning of the study
Tidsram: 18 months
18 months
Presence/absence of side effects noted in the summary of product characteristics for sunitinib
Tidsram: 18 months
18 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Utredare

  • Studierektor: Litaty Mbatchi, PharmD, Centre Hospitalier Universitaire de Nīmes

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 december 2015

Primärt slutförande (Faktisk)

21 maj 2019

Avslutad studie (Faktisk)

21 maj 2019

Studieregistreringsdatum

Först inskickad

26 mars 2015

Först inskickad som uppfyllde QC-kriterierna

30 mars 2015

Första postat (Uppskatta)

31 mars 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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