Metastatic Kidney CancerBIOSUNTOXNCT03846128
Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
An observational study of Metastatic Kidney Cancer, run by University Hospital, Rouen at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Kidney Cancer
- What is being tested?
- blood sample
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2019to 8 Oct 2021
- 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: Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- blood sample
- 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 sampleBiological
blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1
What is being measured
The primary outcome is the main question the study is designed to answer.
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Measured: At the end of Cycle 6 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Measured: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes (10)
plasma desethyl-Sunitinib (DES) concentration
influence of plasma DES concentration on patients survival
Measured: Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration
influence of plasma Sunitinib concentration on patients survival
Measured: Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration
influence of plasma Sunitinib concentration on patients survivall
Measured: Cycle1 Day28 (each cycle is 28 days)
plasma DES concentration
influence of plasma Sunitinib concentration on patients survival
Measured: Cycle1 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
influence of plasma Sunitinib concentration on patients survival
Measured: Cycle2 Day28(each cycle is 28 days)
plasma DES concentration
influence of plasma DES concentration on patients survival
Measured: Cycle2 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
influence of plasma Sunitinib concentration on patients survival
Measured: Cycle3 Day28 (each cycle is 28 days)
plasma DES concentration
Evaluate the influence of plasma DES concentration on patients survival
Measured: Cycle3 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
influence of plasma Sunitinib concentration on patients survival
Measured: Cycle6 Day28 (each cycle is 28 days)
plasma DES concentration
influence of plasma DES concentration on patients survival
Measured: Cycle6 Day28 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start3 Jun 2019
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Kidney CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846128
- Sponsor's protocol ID
- 2017/181/HP
- Acronym
- BIOSUNTOX
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer
- ClinicalTrials.gov ID
- NCT03846128
- Acronym / sponsor ID
- BIOSUNTOX / 2017/181/HP
- Conditions
- Metastatic Kidney Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 19 Feb 2019 (actual)
- 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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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 sampleblood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1 | Biological | – |
Primary outcome
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
Time frame: At the end of Cycle 6 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 1 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 2 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 3 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 4 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 5 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
Time frame: At the end of Cycle 6 (each cycle is 28 days)
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib
10 secondary outcomes
plasma desethyl-Sunitinib (DES) concentration
Time frame: Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration
Time frame: Cycle1 Day14 (each cycle is 28 days)
plasma Sunitinib concentration
Time frame: Cycle1 Day28 (each cycle is 28 days)
plasma DES concentration
Time frame: Cycle1 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
Time frame: Cycle2 Day28(each cycle is 28 days)
plasma DES concentration
Time frame: Cycle2 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
Time frame: Cycle3 Day28 (each cycle is 28 days)
plasma DES concentration
Time frame: Cycle3 Day28 (each cycle is 28 days)
plasma Sunitinib concentration
Time frame: Cycle6 Day28 (each cycle is 28 days)
plasma DES concentration
Time frame: Cycle6 Day28 (each cycle is 28 days)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Kidney Cancer, run by University Hospital, Rouen at 1 site 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: 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.). Results are not available in the source record.
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?
hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.