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

28. januar 2020 oppdatert 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

43

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. desember 2015

Primær fullføring (Faktiske)

21. mai 2019

Studiet fullført (Faktiske)

21. mai 2019

Datoer for studieregistrering

Først innsendt

26. mars 2015

Først innsendt som oppfylte QC-kriteriene

30. mars 2015

Først lagt ut (Anslag)

31. mars 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

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