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

NCT ID: NCT03846128

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2024-05-31

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)

Conditions

Metastatic Kidney Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

blood sample

blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2017/181/HP

Identifier Type: -

Identifier Source: org_study_id