Regulatory Post Marketing Surveillance Study on Nexavar®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01012011
First received: November 10, 2009
Last updated: July 10, 2015
Last verified: July 2015
  Purpose

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

n.a


Estimated Enrollment: 3000
Study Start Date: September 2009
Estimated Study Completion Date: July 2015
Primary Completion Date: January 2015 (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.

Detailed Description:

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

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

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

Criteria

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.
  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 ClinicalTrials.gov identifier: NCT01012011

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01012011     History of Changes
Other Study ID Numbers: 14792, NX0910KR
Study First Received: November 10, 2009
Last Updated: July 10, 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
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Kidney Diseases
Kidney Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 27, 2015