Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

• Conditions: Metastatic Kidney Cancer

• Registration Number: NCT03846128
• Lead Sponsor: University Hospital, Rouen

Brief Summary

Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer.

Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23
• Study Start: 2019-08
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patient at least 18 years old
• Patient who read and understood the newsletter and signed the consent form
• Renal cell carcinoma histologically proven stage IV
• Metastatic stage proven on CT, synchronous or metachronous examination
• Patient operated on or not from the primary tumor
• Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology
• Affiliation to a social security scheme
• Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test)
• Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit)
• General condition WHO 0 to 2
• Life expectancy estimated at more than 6 months at baseline

Exclusion Criteria

• Non-metastatic disease
• Other cancer proven histologically, or in complete remission for less than 2 years
• Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients
• History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer
• Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception,
• Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship
• Patient currently involved in an interventional trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 6 (each cycle is 28 days)	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib	At the end of Cycle 6 (each cycle is 28 days)	hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib

Secondary Outcome Measures

Name	Time	Method
plasma Sunitinib concentration	Cycle6 Day28 (each cycle is 28 days)	influence of plasma Sunitinib concentration on patients survival
plasma DES concentration	Cycle6 Day28 (each cycle is 28 days)	influence of plasma DES concentration on patients survival
plasma desethyl-Sunitinib (DES) concentration	Cycle1 Day14 (each cycle is 28 days)	influence of plasma DES concentration on patients survival