Advanced Renal Cell Carcinoma, With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy

Bayer

Status: Terminated

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sorafenib (Nexavar, BAY43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01195649

15242

NX1010TW (Other Identifier)

Details and patient eligibility

About

The primary objective of this prospective, observational, post-marketing study is to evaluate the patient characteristics, pre-treatment and treatment duration in Renal Cell Carcinoma (RCC) patients who are candidates for systematic therapy and in whom a decision to treat with Nexavar® has been made under real-life practice settings and approved reimbursement restriction in Taiwan. Therefore, the main objective of the study is to collect data on:

Prescription pattern: to determine the factors affecting compliance and duration of treatment with special attention given to education status, demography, disease details, pre-treatment, concomitant medication and other baseline data

Nexavar® treatment and efficacy data

Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Nexavar® under Taiwan reimbursement guideline
• Patients must have a life expectancy of at least 8 weeks

Exclusion criteria

• Exclusion criteria must follow the approved local product information.
• Patients were lost to follow-up if no follow-up visit and no final assessment of Nexavar® was documented.

Trial design

11 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)