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Regorafenib Post-marketing Surveillance

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Bayer

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Observational

Funder types

Industry

Identifiers

NCT01843400
16472
STIVARGA-CRC-01 (Other Identifier)

Details and patient eligibility

About

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

Enrollment

1,301 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Patients

  • who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

  • Patients who have previously received Regorafenib/ STIVARGA

Trial design

1,301 participants in 1 patient group

Group 1
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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