NCT00716625

Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)

Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,674 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
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."

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2008-07-16
• Last updated: 2023-05-03
• Results posted: 2017-01-18