Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

Completed

• Conditions: Colorectal Neoplasm
• Interventions: Drug: Regorafenib (Stivarga, BAY 73-4506)

• Registration Number: NCT01959269
• Lead Sponsor: Bayer

Brief Summary

The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Study Start: 2013-10-31
• Primary Completion: 2017-03-31
• Study Completion: 2017-07-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

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• Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga.
• Patients must have signed an informed consent form

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regorafenib	Regorafenib (Stivarga, BAY 73-4506)	Patients treated with Stivarga as 3rd or 4th line treatment, no intervention

Primary Outcome Measures

Name	Time	Method
Overall survival	after 40 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	after 40 months
Time to progression	after 40 months
Disease control rate (DCR)	after 40 months	Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease).
Duration of Stivarga treatment	after 40 months	Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation)
Tumor status at different visits	after 40 months	The tumor status at different visits will be evaluated according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable". The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.
Incidence of treatment emergent adverse events (TEAE)	after 18 and 40 months	Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug.