CClinicalTrials.gg
CompletedNCT01012011Updated Sep 21, 2015

Regulatory Post Marketing Surveillance Study on Nexavar®

An observational study in Carcinoma, Hepatocellular and Carcinoma, Renal Cell, sponsored by Bayer. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 91 Years. Per ClinicalTrials.gov, last updated 2015-09-21.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,845
Ages
20 Years to 91 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell

Keywords

  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 2,845 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 91 Years
Sexes eligible
All
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 RCC or HCC and decision taken by the physician to prescribe Nexavar.

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,845 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

  • DrugSorafenib (Nexavar, BAY43-9006)

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

06

What researchers measure

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

07

Study locations

1 site
  • Many Locations, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01012011
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Nov 11, 2009
Start date
Sep 2009
Primary completion
Jan 2015
Completion
Aug 2015
Last update
Sep 21, 2015

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion