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Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer | Clinical Trials | Clareo Health

UNKNOWN

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

NCT03846128•University Hospital, Rouen

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Key Dates

Start Date

August 1, 2019

Primary Completion Date

May 1, 2024

Completion Date

May 1, 2024

Last Updated

July 23, 2019

Enrollment

ESTIMATED participants

Conditions

Metastatic Kidney Cancer

Interventions

blood sample

BIOLOGICAL

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

CARE1 Pragmatic Clinical Trial

Immunotherapy Study for Metastatic Renal Cell Cancer

ELR+CXCL Cytokines in Metastatic Kidney Cancers: Predictive Markers of Resistance to Sunitinib

Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer