Trial Condition(s):

Neoplasms

Safety and Effectiveness of Regorafenib (Correlate)

Bayer Identifier:

16821

ClinicalTrials.gov Identifier:

NCT02042144

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study is a prospective observational cohort study.
The study will be conducted in routine clinical practice
settings. It is planned to enroll 1000 patients with
metastatic Colorectal Cancer (mCRC) who have been
previously treated with other approved treatments for
metastatic disease and for whom a decision has been
made by the physician to treat with regorafenib
according to local health authority approved label. It is
the aim of this observational cohort study to further
characterize safety and effectiveness of regorafenib in
routine clinical practice setting.
Healthcare resource utilization in the routine provision of
care is becoming increasingly important from a health
economics and outcomes research perspective.
Therefore, another aim of this observational cohort
study is to capture healthcare resource associated with
the management of treatment emergent adverse events
in the real world setting.
The primary objective of this study is to further
characterize safety of regorafenib use in routine clinical
practice settings.
The secondary objective of this study is to assess the
effectiveness of regorafenib in routine clinical practice
settings as measured by Overall Survival (OS),
Progression Free Survival (PFS) and Disease control
rate (DCR). Health Related Quality of Life (HRQoL)
Data will be collected in applicable countries.

Inclusion Criteria
-  Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator’s routine treatment practice to prescribe regorafenib.
Exclusion Criteria
-  Patients participating in an investigational program with interventions outside of routine clinical practice

Trial Summary

Enrollment Goal
1034
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Netherlands

Status
Completed
 
Locations

Investigative Site

Many Locations, Mexico

Status
Completed
 
Locations

Investigative Site

Many Locations, Austria

Status
Completed
 
Locations

Investigative Site

Many Locations, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Many Locations, Switzerland

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Denmark

Status
Completed
 
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many Locations, Singapore

Status
Completed
 
Locations

Investigative Site

Many Locations, Luxembourg

Status
Completed
 
Locations

Investigative Site

Many Locations, Argentina

Status
Completed
 

Trial Design