Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 8 of 72 for:    regorafenib

Regorafenib Post-marketing Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 26, 2013
Last updated: November 23, 2014
Last verified: November 2014

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.

Condition Intervention
Colorectal Neoplasms
Drug: BAY73-4506_Regorafenib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of patient's background to affect the safety and efficacy of Regorafenib using standard observational survey and follow-up survey [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 1250
Study Start Date: April 2013
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: BAY73-4506_Regorafenib
Patients treated with Regorafenib under practical manner for colorectal cancer.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with unresectable, metastatic or recurrent colorectal cancer


Inclusion Criteria:Patients

  • who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

  • Patients who have previously received Regorafenib/ STIVARGA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01843400

Contact: Bayer Clinical Trials Contact

Many Locations, Japan
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT01843400     History of Changes
Other Study ID Numbers: 16472, STIVARGA-CRC-01
Study First Received: April 26, 2013
Last Updated: November 23, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Colorectal Neoplasms

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on November 24, 2014