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

tiistai 28. tammikuuta 2020 päivittänyt: 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).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

43

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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
Geneettinen: Blood drawn for genotyping
Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
Biologinen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
Aikaikkuna: 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*

Toissijaiset tulostoimenpiteet

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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Centre Hospitalier Universitaire de Nīmes

Tutkijat

  • Opintojohtaja: Litaty Mbatchi, PharmD, Centre Hospitalier Universitaire De Nimes

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 29. joulukuuta 2015

Ensisijainen valmistuminen (Todellinen)

Tiistai 21. toukokuuta 2019

Opintojen valmistuminen (Todellinen)

Tiistai 21. toukokuuta 2019

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 26. maaliskuuta 2015

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 30. maaliskuuta 2015

Ensimmäinen Lähetetty (Arvio)

Tiistai 31. maaliskuuta 2015

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 29. tammikuuta 2020

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 28. tammikuuta 2020

Viimeksi vahvistettu

Keskiviikko 1. tammikuuta 2020

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Munuaisten kasvaimet

Kliiniset tutkimukset Blood drawn for genotyping

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