Clinical trial · Observational
The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer
The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants
NCT02404584CI-TRIAL-00098374GenCInibs-SunicompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine the percentage of patients with a plasma concentration of sunitinib remaining at equilibrium (\[Suni\]REq) greater than 100 ng / ml (effective concentration according to the current literature).
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 |
|---|---|---|---|
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood drawn for genotyping | Genetic | — | UNRESOLVED |
| Blood drawn for pharmacokinetic measures | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- The study population
- description
- Patients with kidney cancer and will be starting treatment via sunitinib at the study start will be included. Intervention: Blood drawn for genotyping Intervention: Blood drawn for pharmacokinetic measures
- interventionNames
- Genetic: Blood drawn for genotyping
- Biological: Blood drawn for pharmacokinetic measures
Primary outcomes (1)
- measure
- The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
- timeFrame
- Between C1D15* and C1D28*
- description
- \*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal). Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order. Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle.
Secondary outcomes (20)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient was correctly informed concerning the implementation of the study, its objectives, constraints and patient rights * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient has kidney cancer and should begin treatment with sunitinib (Sutent) at the time of inclusion Exclusion Criteria: * The patient started treatment with sunitinib (Sutent) before inclusion * The patient is participating in another interventional study * The patient has participated in another interventional study within the last month * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The patient has a contraindication (or an incompatible drug combination) for a treatment used in this study
References
Publications (1)
- RESULTMbatchi LC, Leenhardt F, Occean BV, Perrin O, Boyer JC, Gongora C, Pourquier P, Mura T, Chapelle A, Topart D, Evrard A, Houede N. Genetic polymorphisms of VEGFR2 and FGFR2 genes are associated with exposure to sunitinib and cardiovascular toxicity. Pharmacogenomics. 2025 Sep-Oct;26(13-14):485-493. doi: 10.1080/14622416.2025.2579001. Epub 2025 Nov 24. PMID 41277563