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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Kidney Cancer
• Intervention / Treatment: Biological: blood sample

• Study Type: Observational
• Enrollment (Anticipated): 64

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 1 (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 biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 2 (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 biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 3 (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 biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 4 (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 biologicalas according to the plasma concentration of Sunitinib	At the end of Cycle 5 (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 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 biological according to the plasma concentration of desethyl-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 1 (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	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 2 (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	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 3 (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	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 4 (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	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 5 (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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma desethyl-Sunitinib (DES) concentration	influence of plasma DES concentration on patients survival	Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survivall	Cycle1 Day28 (each cycle is 28 days)
plasma DES concentration	influence of plasma Sunitinib concentration on patients survival	Cycle1 Day28 (each cycle is 28 days)
plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle2 Day28(each cycle is 28 days)
plasma DES concentration	influence of plasma DES concentration on patients survival	Cycle2 Day28 (each cycle is 28 days)
plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle3 Day28 (each cycle is 28 days)
plasma DES concentration	Evaluate the influence of plasma DES concentration on patients survival	Cycle3 Day28 (each cycle is 28 days)
plasma Sunitinib concentration	influence of plasma Sunitinib concentration on patients survival	Cycle6 Day28 (each cycle is 28 days)
plasma DES concentration	influence of plasma DES concentration on patients survival	Cycle6 Day28 (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 2017/181/HP