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OpenTrials
Completed

NCT Number: NCT01012011

Regulatory Post Marketing Surveillance Study on Nexavar®

This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Carcinoma, Renal Cell Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–91 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, South Korea

About this study

The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.

  • Unknown adverse events (in particular, serious adverse events)
  • Identification of adverse events occurred in the real practice.
  • Factors that are considered to affect on safety.
  • Factors that are considered to affect on effectiveness

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.

Exclusion criteria

  • Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Daily dose, dosage frequency and duration will be decided by physicians.

Primary outcomes

  1. Adverse events collection

    Time frame: From start of treatment to 4 weeks after discontinuation of treatment

Secondary outcomes

  1. Duration of treatment, dosage and indication

    Time frame: Whole treatment period

  2. Tumor status

    Time frame: Whole treatment period

  3. Performance status

    Time frame: Whole treatment period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2009
Registry last updated
Sep 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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