Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy (SOGUG/0107)
This study has been completed.
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group
First received: April 21, 2008
Last updated: December 17, 2014
Last verified: November 2007
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.
Carcinoma Renal Cells
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Progression-free survival [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global survival [ Time Frame: At last contact date or death date ] [ Designated as safety issue: No ]
- Response global [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
- Security and tolerability of Sunitinib [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
This study has only one arm with Sunitinib
Sunitinib 50mg oral in the morning during 4 weeks with 2 weeks of break.
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:
|Accepts Healthy Volunteers:
- Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
- Patients that have received sistemic treatment previous to metastasic disease.
- Previous nefrectomy.
- Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
- Radiotherapy upper > 25% bone marrow.
- Patients that are participating in any clinical trial.
- Patients with a primary cancer diagnosis in thast 3 years, except superficial basaliomas, superficial escamous carcinoma or in situ cervix carcinoma with aducuate treatment.
- Following events in the last 12 months previous to begin the treatment: myocardial infarction, unstable o severe angina, coronary/periferic place of arterial by-pass, congestive cardiac insufficiency, brain-vascular accident included transitory ischemia or lung embolism.
- Arterial uncontrolled hypertension nor controlated with drugs ( >150/100 mmHg despite adequate medical treatment).
- Cardiac arrhythmia with grade NCI CTCAE ≥2, auricular fibrillation all grade and/or QTc interval> 450mseg in men and > 470 mseg in women.
- Actually treatment with therapeutic dose with acenocumarol (except low dose for deep venous thrombosis).
- Patients that present previously known positive serology for HIV.
- Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00663559
|Hospital Central de Asturias
|Oviedo, Asturias, Spain, 33006 |
|Hospital Parc Taulí
|Sabadell, Barcelona, Spain, 08208 |
|Barcelona, Spain, 08036 |
|Hospital Reina Sofía
|Córdoba, Spain, 14004 |
|Hospital de Jaén
|Jaén, Spain, 23007 |
|Hospital Clínico San Carlos
|Madrid, Spain, 28040 |
|Hospital lozano Blesa
|Zaragoza, Spain, 50009 |
Spanish Oncology Genito-Urinary Group
||José Luís González Larriba, MD
No publications provided
||Spanish Oncology Genito-Urinary Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 21, 2008
||December 17, 2014
||Spain: Spanish Agency of Medicines
Keywords provided by Spanish Oncology Genito-Urinary Group:
Unresectable and/or metastatic renal cell cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 08, 2015
Carcinoma, Renal Cell
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Angiogenesis Modulating Agents
Physiological Effects of Drugs