Clinical trial NCT03846128: Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
Official title: Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Kidney Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer

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)


Eligibility criteria: 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

Primary outcomes:
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 4 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 5 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 2 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 3 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 4 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 5 (each cycle is 28 days)
measure: hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes:
measure: plasma desethyl-Sunitinib (DES) concentration
timeFrame: Cycle1 Day14 (each cycle is 28 days)
measure: plasma Sunitinib concentration
timeFrame: Cycle1 Day14 (each cycle is 28 days)
measure: plasma Sunitinib concentration
timeFrame: Cycle1 Day28 (each cycle is 28 days)
measure: plasma DES concentration
timeFrame: Cycle1 Day28 (each cycle is 28 days)
measure: plasma Sunitinib concentration
timeFrame: Cycle2 Day28(each cycle is 28 days)
measure: plasma DES concentration
timeFrame: Cycle2 Day28 (each cycle is 28 days)
measure: plasma Sunitinib concentration
timeFrame: Cycle3 Day28 (each cycle is 28 days)
measure: plasma DES concentration
timeFrame: Cycle3 Day28 (each cycle is 28 days)
measure: plasma Sunitinib concentration
timeFrame: Cycle6 Day28 (each cycle is 28 days)
measure: plasma DES concentration
timeFrame: Cycle6 Day28 (each cycle is 28 days)
Other outcomes:
Locations:
Study officials:
References: