Regulatory Post Marketing Surveillance Study on Nexavar®
This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01012011
First received: November 10, 2009
Last updated: April 3, 2013
Last verified: April 2013
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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: | October 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 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.
|
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01012011
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Korea, Republic of | |
| Recruiting | |
| 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: | Medical Director, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01012011 History of Changes |
| Other Study ID Numbers: | 14792, NX0910KR |
| Study First Received: | November 10, 2009 |
| Last Updated: | April 3, 2013 |
| 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, Renal Cell Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Liver Neoplasms Digestive System Neoplasms Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013