Safety and Effectiveness of Regorafenib

NCT ID: NCT02042144

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1034 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-08
• Study Completion Date: 2017-11-10

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.

Conditions

Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Stivarga (Regorafenib, BAY73-4506)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Multiple Locations, , Argentina

Multiple Locations, , Austria

Multiple Locations, , Czechia

Multiple Locations, , Denmark

Multiple Locations, , France

Multiple Locations, , Italy

Multiple Locations, , Luxembourg

Multiple Locations, , Mexico

Multiple Locations, , Netherlands

Multiple Locations, , Singapore

Multiple Locations, , Spain

Multiple Locations, , Switzerland

Multiple Locations, , Taiwan

Countries

Argentina; Austria; Czechia; Denmark; France; Italy; Luxembourg; Mexico; Netherlands; Singapore; Spain; Switzerland; Taiwan

References

Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, Feliu J, Carmen Guillen-Ponce, Paredes BG, Carral A, Munoz J. Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence. Future Oncol. 2024;20(20):1401-1413. doi: 10.1080/14796694.2024.2340422. Epub 2024 Jun 11.

Reference Type: DERIVED

PMID: 38861286 (View on PubMed)

Yeh KH, Yang TS, Hsu TC, Tzu-Liang Chen W, Chen HH, Teng HW, Lin BW, Kuan FC, Chiang FF, Duann CW, Li YS, Lin MT, Fiala-Buskies S, Ducreux M, Wang JY. Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan. J Formos Med Assoc. 2021 Nov;120(11):2023-2031. doi: 10.1016/j.jfma.2020.12.015. Epub 2021 Jan 7.

Reference Type: DERIVED

PMID: 33422398 (View on PubMed)

Ducreux M, Petersen LN, Ohler L, Bergamo F, Metges JP, de Groot JW, Wang JY, Garcia Paredes B, Dochy E, Fiala-Buskies S, Cervantes A, O'Connor JM, Falcone A; CORRELATE Investigators. Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study. Eur J Cancer. 2019 Dec;123:146-154. doi: 10.1016/j.ejca.2019.09.015. Epub 2019 Nov 4.

Reference Type: DERIVED

PMID: 31698328 (View on PubMed)

Other Identifiers

SV1302

Identifier Type: OTHER

Identifier Source: secondary_id

16821

Identifier Type: -

Identifier Source: org_study_id