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| ID | Type | Description | Link |
|---|---|---|---|
| CALACASS-SUVEGIL-8 | |||
| 2008/20 | |||
| INCA-RECF0943 | |||
| EUDRACT-2008-004137-21 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUVEGIL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug |
| ||
| laboratory biomarker analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Disease response | 5 years | |
| VEGF and IL-8 blood levels determined before and every 6 weeks during treatment | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Length of the response | up to 5 years | |
| Disease-free survival | up to 5 years | |
| Overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
Metastatic disease requiring first-line treatment with sunitinib malate
No symptomatic or uncontrolled cerebral metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Marc Ferrero, MD | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36810959 | Derived | 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. | |
| 29563634 |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| pharmacological study | Other |
|
| up to 5 years |
| Polena 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |