Regorafenib Post-marketing Surveillance in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: August 29, 2013
Last updated: April 15, 2016
Last verified: April 2016
The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

Condition Intervention
Gastrointestinal Stromal Tumors
Drug: Regorafenib (Stivarga, BAY73-4506)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy

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 ]
  • Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • time to treatment failure (TTF) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    TTF is defined as the time interval from start of Regorafenib/ STIVARGA therapy to the date of permanent discontinuation for any reason including disease progression, adverse event, patient preference or death.

  • tumour response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)

Estimated Enrollment: 135
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.
Drug: Regorafenib (Stivarga, BAY73-4506)
The usual dosage is 160 mg of Regorafenib/ STIVARGA taken orally after meal once daily for 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.

Detailed Description:

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 gastrointestinal stromal tumors progressed after cancer chemotherapy.

A total of 135 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months and 24 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are treated with Regorafenib/STIVARGA and meet the product label

Inclusion Criteria:

  • Patients who are treated with Regorafenib/ STIVARGA and meet the product label

Exclusion Criteria:

  • Patients who are treated with Regorafenib/ STIVARGA and don't meet the product label
  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: NCT01933958

Contact: Bayer Clinical Trials Contact

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT01933958     History of Changes
Other Study ID Numbers: 16732  STIVARGA-GIST-01 
Study First Received: August 29, 2013
Last Updated: April 15, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Gastrointestinal stromal tumors

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue processed this record on May 05, 2016