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The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer

NCT02404584 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-12-04

No results posted yet for this study

Summary

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).

Conditions

  • Kidney Neoplasms

Interventions

GENETIC

Blood drawn for genotyping

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

BIOLOGICAL

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Litaty Mbatchi, PharmD · Centre Hospitalier Universitaire de Nîmes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-29
Primary Completion
2019-05-21
Completion
2019-05-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404584 on ClinicalTrials.gov