Spots Global Cancer Trial Database for Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma
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Trial Identification
Brief Title: Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma
Official Title: Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma
Study ID: NCT02555748
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU DE BORDEAUX - Hôpital Saint-André, Bordeaux, , France
Institut Bergonie, Bordeaux, , France
CHU DE LIMOGES - Hôpital Dupuytren, Limoges, , France
Centre Leon Berard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
Institut Regional Du Cancer Montpellier, Montpellier, , France
CH RODEZ, Rodez, , France
Institut Claudius Regaud, Toulouse, , France
Contact Details
Name: Christine CHEVREAU, MD
Affiliation: IUCT-O
Role: PRINCIPAL_INVESTIGATOR
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