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Regorafenib Post-marketing Surveillance in Japan

This study is currently recruiting participants.
Verified October 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01933958
First Posted: September 2, 2013
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 ]
  • Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. [ Time Frame: Up to 6 months ]
  • Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib [ Time Frame: up to 6 months ]

Secondary Outcome Measures:
  • overall survival (OS) [ Time Frame: Up to 3 years ]
  • time to treatment failure (TTF) [ Time Frame: Up to 3 years ]
    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 ]
  • Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor. [ Time Frame: Up to 3 years ]
    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
Actual Study Start Date: September 4, 2013
Estimated Study Completion Date: June 25, 2021
Estimated Primary Completion Date: June 25, 2021 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933958


Contacts
Contact: Bayer Clinical Trials Contact 49 30 300139003 clinical-trials-contact@bayer.com

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01933958     History of Changes
Other Study ID Numbers: 16732
STIVARGA-GIST-01 ( Other Identifier: company internal )
First Submitted: August 29, 2013
First Posted: September 2, 2013
Last Update Posted: October 23, 2017
Last Verified: October 2017

Keywords provided by Bayer:
Regorafenib
Gastrointestinal stromal tumors

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