Safety and Effectiveness of Regorafenib

Completed

• Conditions: Neoplasms
• Interventions: Drug: Stivarga (Regorafenib, BAY73-4506)

• Registration Number: NCT02042144
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Study Start: 2014-04-08
• Primary Completion: 2017-08-19
• Study Completion: 2017-11-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

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.

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Exclusion Criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Stivarga (Regorafenib, BAY73-4506)	-

Primary Outcome Measures

Name	Time	Method
Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3	Up to 42 months

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.	Up to 42 months
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.	Up to 42 months
Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries	Up to 42 months
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.	Up to 42 months
Healthcare resource utilization	Up to 42 months	Hospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapies