- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933958
Regorafenib Post-marketing Surveillance in Japan
Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Multiple Locations, Japan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients treated with Regorafenib under practical manner for gastrointestinal stromal tumors progressed after cancer chemotherapy.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
Time Frame: Up to 6 months
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Up to 6 months
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Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
Time Frame: Up to 6 months
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Up to 6 months
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Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
Time Frame: up to 6 months
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: Up to 3 years
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Up to 3 years
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time to treatment failure (TTF)
Time Frame: Up to 3 years
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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.
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Up to 3 years
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tumour response
Time Frame: Up to 3 years
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Up to 3 years
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Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.
Time Frame: Up to 3 years
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Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)
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Up to 3 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16732
- STIVARGA-GIST-01 (OTHER: company internal)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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