Status:
UNKNOWN
Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
Lead Sponsor:
University Hospital, Rouen
Conditions:
Metastatic Kidney Cancer
Eligibility:
All Genders
18+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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 Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03846128
Start Date
August 1 2019
End Date
May 1 2024
Last Update
July 23 2019
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