ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effectiveness of Regorafenib (Correlate)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02042144
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Neoplasms Drug: Stivarga (Regorafenib, BAY73-4506)

Study Type : Observational
Actual Enrollment : 1034 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings
Actual Study Start Date : April 8, 2014
Actual Primary Completion Date : August 19, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Group/Cohort Intervention/treatment
Group 1 Drug: Stivarga (Regorafenib, BAY73-4506)
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




Primary Outcome Measures :
  1. Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3 [ Time Frame: Up to 42 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause. [ Time Frame: Up to 42 months ]
  2. Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first. [ Time Frame: Up to 42 months ]
  3. Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration. [ Time Frame: Up to 42 months ]
  4. Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries [ Time Frame: Up to 42 months ]
  5. Healthcare resource utilization [ Time Frame: Up to 42 months ]
    Hospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapies



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042144


Locations
Argentina
Multiple Locations, Argentina
Austria
Multiple Locations, Austria
Czechia
Multiple Locations, Czechia
Denmark
Multiple Locations, Denmark
France
Multiple Locations, France
Italy
Multiple Locations, Italy
Luxembourg
Multiple Locations, Luxembourg
Mexico
Multiple Locations, Mexico
Netherlands
Multiple Locations, Netherlands
Singapore
Multiple Locations, Singapore
Spain
Multiple Locations, Spain
Switzerland
Multiple Locations, Switzerland
Taiwan
Multiple Locations, Taiwan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02042144     History of Changes
Other Study ID Numbers: 16821
SV1302 ( Other Identifier: Company internal )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Keywords provided by Bayer:
Neoplasms, Colorectal