Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

Pfizer

Status: Completed

Conditions: Renal Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT02533258

NCT02533258 (Registry Identifier)

A4061076

Details and patient eligibility

About

This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.

Full description

This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed as advanced RCC by histology or cytology
• Patients using axitinib as therapy after failure of sunitinib or cytokine
• Patients received axitinib treatment and follow up in the health care center participating present registry
• Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available

Exclusion criteria

• Patients with first dose of axitinib earlier than 7th May 2013
• Patients with first dose of axitinib later than 30th June 2015.
• Patients participating in clinical research involving axitinib
• Patients with hypersensitivity to axitinib or to any other component of axitinib
• Patients under 18-year of age
• Pregnant women.