Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Regulatory Post Marketing Surveillance Study on Nexavar®

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bayer Identifier:
First received: November 10, 2009
Last updated: February 24, 2015
Last verified: February 2015

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

Condition Intervention
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Drug: Sorafenib (Nexavar, BAY43-9006)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance Study on Nexavar®

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Adverse events collection [ Time Frame: From start of treatment to 4 weeks after discontinuation of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of treatment, dosage and indication [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]
  • Tumor status [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]
  • Performance status [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained


Estimated Enrollment: 3000
Study Start Date: September 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Daily dose, dosage frequency and duration will be decided by physicians.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diagnosis of advanced renal cell carcinoma or hepatocellular carcinoma and decision taken by the physician to precribe Nexavar


Inclusion Criteria:

  • Patients with diagnosis of advanced Renal Cell Carcinoma and Hepatocellular carcinoma and decision taken by the physician to prescribe Nexavar

Exclusion Criteria:

  • Hypersensitivity to the active substances or any of gradient of the study drug ingredients (according to the local product information)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01012011

Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01012011     History of Changes
Other Study ID Numbers: 14792, NX0910KR
Study First Received: November 10, 2009
Last Updated: February 24, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Carcinoma, Hepatocellular
Carcinoma, Renal Cell

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Digestive System Diseases
Digestive System Neoplasms
Kidney Diseases
Kidney Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on March 03, 2015