Regulatory Post Marketing Surveillance Study on Nexavar®

Carcinoma, Hepatocellular Clinical Trial

Official title:

Regulatory Post Marketing Surveillance Study on Nexavar®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012011
• Other study ID #: 14792
• Secondary ID: NX0910KR
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: September 18, 2015
• Start date: September 2009
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2845
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 91 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Daily dose, dosage frequency and duration will be decided by physicians.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events collection		From start of treatment to 4 weeks after discontinuation of treatment	Yes
Secondary	Duration of treatment, dosage and indication		Whole treatment period	No
Secondary	Tumor status		Whole treatment period	No
Secondary	Performance status		Whole treatment period	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.