Safety and Effectiveness of Regorafenib (Correlate)

Bayer

Status: Completed

Conditions: Neoplasms

Treatments: Drug: Stivarga (Regorafenib, BAY73-4506)

Study type: Observational

Funder types: Industry

Identifiers

NCT02042144

SV1302 (Other Identifier)

16821

Details and patient eligibility

About

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.

Enrollment: 1,034 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

1,034 participants in 1 patient group

Group 1

Treatment:

Drug: Stivarga (Regorafenib, BAY73-4506)