Regorafenib Post-marketing Surveillance in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01933958
First received: August 29, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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: August 2017
Estimated Primary Completion Date: August 2016 (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.

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01933958

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01933958     History of Changes
Other Study ID Numbers: 16732, STIVARGA-GIST-01
Study First Received: August 29, 2013
Last Updated: September 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Regorafenib
Gastrointestinal stromal tumors

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 21, 2014