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Sponsored by: |
Spanish Oncology Genito-Urinary Group |
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Information provided by: | Spanish Oncology Genito-Urinary Group |
ClinicalTrials.gov Identifier: | NCT00663559 |
The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.
Condition | Intervention | Phase |
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Carcinoma Renal Cells |
Drug: Sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy |
Estimated Enrollment: | 59 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
This study has only one arm with Sunitinib
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Drug: Sunitinib
Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
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Study phase II in with one arm in patients with renal cells carcinoma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with adequate organic function, according to the following criteria:
Exclusion Criteria:
Contact: José Luís González Larriba, MD | 913303000 | jgonzalezl.hcsc@salud.madrid.org |
Contact: Charo Alfonso | 913303000 ext 366 |
Spain | |
Hospital CLINIC | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Begoña Medina, MD 932275400 ext 5523 bmellado@clinic.ub.es | |
Contact: Teresa Vilella 932275402 vilella@clinic.ub.es | |
Principal Investigator: Begoña Mellado, MD | |
Hospital Reina Sofía | Not yet recruiting |
Córdoba, Spain, 14004 | |
Contact: Isabel Jaraba, MD 957011893 datascordoba@yahoo.es | |
Principal Investigator: Enrique Aranda, MD | |
Hospital de Jaén | Recruiting |
Jaén, Spain, 23007 | |
Contact: Capilla De la Torre 953220306 oncojaen@telefonica.net | |
Principal Investigator: Ana Lozano, MD | |
Hospital Clínico San Carlos | Not yet recruiting |
Madrid, Spain, 28040 | |
Contact: Charo Alfonso 913303000 ext 7545 | |
Principal Investigator: José Luís González Larriba, MD | |
Hospital lozano Blesa | Not yet recruiting |
Zaragoza, Spain, 50009 | |
Contact: Mª José Bardina 976765746 | |
Principal Investigator: Julio José Lambea, MD | |
Spain, Asturias | |
Hospital Central de Asturias | Not yet recruiting |
Oviedo, Asturias, Spain, 33006 | |
Contact: Cecilia González 985108000 ceciliagonzalezd@hotmail.com | |
Principal Investigator: Emilio Esteban, MD | |
Spain, Barcelona | |
Hospital Parc Taulí | Recruiting |
Sabadell, Barcelona, Spain, 08208 | |
Contact: Merce Abad 937231010 mabad@cspt.es | |
Principal Investigator: Enrique Gallardo, MD |
Study Chair: | José Luís González Larriba, MD | SOGUG |
Responsible Party: | Spanish Oncology Genito-Urinary Group ( Dr. Bellmunt Molins ) |
Study ID Numbers: | SOGUG/0107 |
Study First Received: | April 21, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00663559 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
renal Sunitinib Unresectable and/or metastatic renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Sunitinib Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site |
Urologic Diseases Kidney Neoplasms Sunitinib Therapeutic Uses Carcinoma, Renal Cell Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |