Kidney CancerNCT00943839
Sunitinib Malate in Treating Patients With Kidney Cancer
A study testing sunitinib malate, laboratory biomarker analysis and pharmacological study in people with Kidney Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- sunitinib malate, laboratory biomarker analysis and pharmacological study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Dec 2014
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Metastatic disease requiring first-line treatment with sunitinib malate
- No prior therapy for metastatic disease
- No symptomatic or uncontrolled cerebral metastasis
PATIENT CHARACTERISTICS:
- Affiliation to the French Social insurance
- Life expectancy ≥ 3 months
- No heart failure
- No chronic unstable disease
- No long QT interval
- No history of another primary cancer
- No severe, uncontrolled acute infection
- No severe, uncontrolled hypertension
- No psychological disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.
Secondary
- To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.
- Conditions
- Kidney Cancer
- Being tested
- sunitinib malate, laboratory biomarker analysis, pharmacological study
- Keywords
- stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| SUVEGIL | Experimental | Not described Receives: Drug: sunitinib malate; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease response
Measured: 5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
Measured: 5 years
Secondary outcomes (3)
Length of the response
Measured: up to 5 years
Disease-free survival
Measured: up to 5 years
Overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc Ferrero, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943839
- Sponsor's protocol ID
- CDR0000638415
- Other IDs
- CALACASS-SUVEGIL-8, 2008/20, INCA-RECF0943, EUDRACT-2008-004137-21
- Status last verified
- Nov 2015
- First submitted
- 21 Jul 2009
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Montemagno C, Durivault J, Gastaldi C, Dufies M, Vial V, He X, Ambrosetti D, Kamenskaya A, Negrier S, Bernhard JC, Borchiellini D, Cao Y, Pages G. A group of novel VEGF splice variants as alternative therapeutic targets in renal cell carcinoma. Mol Oncol. 2023 Jul;17(7):1379-1401. doi: 10.1002/1878-0261.13401. Epub 2023 Apr 18.
PubMed 36810959Polena H, Creuzet J, Dufies M, Sidibe A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Negrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.
PubMed 29563634
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.
- ClinicalTrials.gov ID
- NCT00943839
- Acronym / sponsor ID
- CDR0000638415
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jul 2009 (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.
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.
Detailed description
OBJECTIVES:
Primary
- To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.
Secondary
- To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUVEGIL | Experimental | Drug: sunitinib malate, Other: laboratory biomarker analysis, Other: pharmacological study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sunitinib malate | Drug | SUVEGIL |
| laboratory biomarker analysis | Other | SUVEGIL |
| pharmacological study | Other | SUVEGIL |
Primary outcome
Disease response
Time frame: 5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
Time frame: 5 years
3 secondary outcomes
Length of the response
Time frame: up to 5 years
Disease-free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
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 10 Nov 2016.
- Derived from this study: PubMed 36810959Montemagno C, Durivault J, Gastaldi C, Dufies M, Vial V, He X, Ambrosetti D, Kamenskaya A, Negrier S, Bernhard JC, Borchiellini D, Cao Y, Pages G. A group of novel VEGF splice variants as alternative therapeutic targets in renal cell carcinoma. Mol Oncol. 2023 Jul;17(7):1379-1401. doi: 10.1002/1878-0261.13401. Epub 2023 Apr 18.
- Derived from this study: PubMed 29563634Polena H, Creuzet J, Dufies M, Sidibe A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Negrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.
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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.
Jean Marc Ferrero, MD principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunitinib malate, laboratory biomarker analysis and pharmacological study in people with Kidney Cancer, run by Centre Antoine Lacassagne 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?
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 10 Nov 2016. 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 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?
Disease response (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT00943839, which also lists 2 linked publications.
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 10 Nov 2016.