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Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

NCT02555748 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-03-31

No results posted yet for this study

Summary

This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study.

Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).

The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.

Conditions

  • Metastatic Renal Cell Cancer

Interventions

DRUG

Pazopanib

DRUG

Sunitinib

Sponsors & Collaborators

  • University Hospital, Bordeaux

    collaborator OTHER

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Christine CHEVREAU, MD · IUCT-O

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-17
Primary Completion
2020-01-16
Completion
2020-01-16

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 NCT02555748 on ClinicalTrials.gov