OncRef

Clinical Trial: NCT02555748

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

Status:

COMPLETED

Phase:

Phase 4

Lead Sponsor:Institut Claudius Regaud
Information Provided By:Institut Claudius Regaud
Last Update Posted:2026-03-31

Study Overview

Brief 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.

Official Title

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

Conditions

Metastatic Renal Cell Cancer

Intervention / Treatment

  • Drug: Pazopanib
  • Drug: Sunitinib

Other Study ID Numbers

  • 14 URO 06

Start Date (Actual)

2015-11-17

Primary Completion Date (Actual)

2020-01-16

Study Completion Date (Actual)

2020-01-16

Enrollment (Actual)

47

Study Type

Interventional

Phase

Phase 4