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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00716625 |
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: sunitinib malate |
Phase IV |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Special Investigation For Renal Cell Carcinoma (RCC) Of Sutent (Regulatory Post Marketing Commitment Plan) |
Estimated Enrollment: | 600 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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sunitinib malate
Patients taking sunitinib malate
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Drug: sunitinib malate
SUTENT® Capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition."
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All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The patients whom an investigator involving A6181176 prescribes the sunitinib malate (Sutent).
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181176 |
Study First Received: | July 15, 2008 |
Last Updated: | August 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00716625 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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 |