Kidney NeoplasmsGenCInibs-SuniNCT02404584
The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer
An observational study of Kidney Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms
- What is being tested?
- Blood drawn for genotyping and Blood drawn for pharmacokinetic measures
- How many people
- 43 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Dec 2015to 21 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of patients with renal cell carcinoma treated with sunitinib (Sutent).
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Institut de Cancérologie du Gard (ICG)
Nîmes, 30029
About this study
Official title: The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants
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).
Read the detailed description
The secondary objectives of this study are:
- To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with
- the [Suni]REq,
- the advent of toxicity,
- the tumor response.
- To describe the variation in the [Suni]REq and the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq) at:
- the interindividual level,
- overtime, between chemotherapy cycles.
- To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) to the [Suni]REq at:
- the interindividual level,
- overtime, between chemotherapy cycles.
- To explore potential correlations between the [Suni]REq and
- toxicity,
- tumor response.
- To explore potential correlations between the [ActEnt]REq and
- toxicity,
- tumor response.
- To explore potential correlations between the ratio [Metab]REq / [Suni]REq and
- toxicity,
- tumor response.
- Conditions
- Kidney Neoplasms
- Being tested
- Blood drawn for genotyping, Blood drawn for pharmacokinetic measures
- Keywords
- Metastatic kidney cancer
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawn for genotypingGenetic
Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
Blood drawn for pharmacokinetic measuresBiological
Blood will be drawn for pharmacokinetic measures between CmD15 and CmD28 of each sunitinib cycle.*
*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.
| Study group | Role | What they receive |
|---|---|---|
| The study population | 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 Receives: Genetic: Blood drawn for genotyping; Biological: Blood drawn for pharmacokinetic measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
*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.
Measured: Between C1D15* and C1D28*
Secondary outcomes (20)
Genotype: genetic polymorphisms of enzymes of phase I, phase II (conjugation), carriers of Phases 0 and III, the nuclear receptors PXR and CAR, pharmacological targets of sunitinib (tyrosine kinase receptors).
Predefined list of genes:
ABCB1 ABCC2 ABCG2 CYP1A1 CYP1A2 CYP2A6 CYP2B6 CYP2C19 CYP2C8 CYP2C9 CYP2D6 CYP2E1 CYP3A4 CYP3A5 NR1I2 NR1I3 SLC15A2 SLC22A1 SLC22A2 SLC22A6 SLCO1B1 SLCO1B3 SULT1A1 UGT1A1 UGT2B15 UGT2B17 UGT2B7 VEGFR1,2,3 PDGFR-α et β KIT
Measured: Baseline (day 0)
[Suni]REq per cure
*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.
Measured: Between CmD15* and CmD28* for 18 months
The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure
Measured: 18 months
Tumor response per cure
Measured: 18 months
Toxicity (yes/no) for each type of toxic event per cure
*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.
Measured: Between CmD15* and CmD28* for 18 months
[Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)
*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.
Measured: Between C1D15* and C1D28*
the average [Suni]REq over all cures
Measured: 18 months
For each cure, the average [Suni]REq for cure 1 to cure m
Measured: 18 months
For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq
*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.
Measured: Between CmD15* and CmD28* for 18 months
[Metab]REq / [Suni]REq
*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.
Measured: Between C1D15* and C1D28*
[Metab]REq / [Suni]REq averaged per initial dosing
*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.
Measured: Between C1D15* and C1D28*
Mean [Metab]REq / [Suni]REq for all cures
Measured: 18 months
For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m
Measured: 18 months
For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)
Measured: 18 months
[ActEnt]REq
*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.
Measured: Between C1D15* and C1D28*
[ActEnt]REq averaged per initial dosing
*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.
Measured: Between C1D15* and C1D28*
Mean [ActEnt]REq for all cures
Measured: 18 months
For each cure, the average [ActEnt]REq for cure 1 to cure m
Measured: 18 months
For each cure, the % of patients whose dosings were modified since the beginning of the study
Measured: 18 months
Presence/absence of side effects noted in the summary of product characteristics for sunitinib
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start29 Dec 2015
- Primary completion21 May 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Litaty Mbatchi, PharmD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404584
- Sponsor's protocol ID
- LOCAL/2014/LM-01bis
- Other IDs
- 2014-005534-55, 2014
- Acronym
- GenCInibs-Suni
- Status last verified
- Nov 2025
- First submitted
- 26 Mar 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mbatchi 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.
PubMed 41277563
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic Variability of Sunitinib in Patients With Metastatic Renal Cancer: Searching for Pharmacogenetic Determinants
- ClinicalTrials.gov ID
- NCT02404584
- Acronym / sponsor ID
- GenCInibs-Suni / LOCAL/2014/LM-01bis
- Conditions
- Kidney Neoplasms
- Keywords
- Metastatic kidney cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 29 Dec 2015 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The secondary objectives of this study are:
- To describe the distribution of constitutional genetic determinants related to sunitinib pharmacokinetics, and to study their correlation with
- the [Suni]REq,
- the advent of toxicity,
- the tumor response.
- To describe the variation in the [Suni]REq and the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq) at:
- the interindividual level,
- overtime, between chemotherapy cycles.
- To describe the variation in the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) to the [Suni]REq at:
- the interindividual level,
- overtime, between chemotherapy cycles.
- To explore potential correlations between the [Suni]REq and
- toxicity,
- tumor response.
- To explore potential correlations between the [ActEnt]REq and
- toxicity,
- tumor response.
- To explore potential correlations between the ratio [Metab]REq / [Suni]REq and
- toxicity,
- tumor response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Genetic: Blood drawn for genotyping, Biological: Blood drawn for pharmacokinetic measuresPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients with renal cell carcinoma treated with sunitinib (Sutent).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawn for genotypingBlood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline). | Genetic | The study population |
| Blood drawn for pharmacokinetic measuresBlood will be drawn for pharmacokinetic measures between CmD15 and CmD28 of each sunitinib cycle.* *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. | Biological | The study population |
Primary outcome
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml
Time frame: Between C1D15* and C1D28*
*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.
20 secondary outcomes
Genotype: genetic polymorphisms of enzymes of phase I, phase II (conjugation), carriers of Phases 0 and III, the nuclear receptors PXR and CAR, pharmacological targets of sunitinib (tyrosine kinase receptors).
Time frame: Baseline (day 0)
[Suni]REq per cure
Time frame: Between CmD15* and CmD28* for 18 months
The presence/absence of grade I, II, III, IV, V (CTCAE version 4.0) toxicities per cure
Time frame: 18 months
Tumor response per cure
Time frame: 18 months
Toxicity (yes/no) for each type of toxic event per cure
Time frame: Between CmD15* and CmD28* for 18 months
[Suni]REq at the 1st cure, averaged per initial dosing (37.5mg, 50 mg, 75 mg, 100mg)
Time frame: Between C1D15* and C1D28*
the average [Suni]REq over all cures
Time frame: 18 months
For each cure, the average [Suni]REq for cure 1 to cure m
Time frame: 18 months
For each cure, the ratio of the plasma concentration of the metabolite remaining at equilibrium ([Metab]REq) / [Suni]REq
Time frame: Between CmD15* and CmD28* for 18 months
[Metab]REq / [Suni]REq
Time frame: Between C1D15* and C1D28*
[Metab]REq / [Suni]REq averaged per initial dosing
Time frame: Between C1D15* and C1D28*
Mean [Metab]REq / [Suni]REq for all cures
Time frame: 18 months
For each cure, the average [Metab]REq / [Suni]REq for cure 1 to cure m
Time frame: 18 months
For each cure, the plasma concentration of the active entity remaining at equilibrium ([ActEnt]REq)
Time frame: 18 months
[ActEnt]REq
Time frame: Between C1D15* and C1D28*
[ActEnt]REq averaged per initial dosing
Time frame: Between C1D15* and C1D28*
Mean [ActEnt]REq for all cures
Time frame: 18 months
For each cure, the average [ActEnt]REq for cure 1 to cure m
Time frame: 18 months
For each cure, the % of patients whose dosings were modified since the beginning of the study
Time frame: 18 months
Presence/absence of side effects noted in the summary of product characteristics for sunitinib
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 41277563Mbatchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Litaty Mbatchi, PharmD study director
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with a plasma concentration of sunitinib remaining at equilibrium ([Suni]REq) greater than 100 ng / ml (time frame: Between C1D15* and C1D28*). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.