Clinical trial · Observational
Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
NCT03846128CI-TRIAL-00108206BIOSUNTOXterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Changes in the indication for Sunitinib in metastatic renal cell carcinoma, which have led to a significant decrease in its use in the urology department. Collected data will not be sufficient to perform a statistical analysis.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Kidney Cancer | Malignant Kidney Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (12)
- 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)
- description
- hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
- 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)
- description
- hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.