Regorafenib Post-marketing Surveillance in Japan

N/ACompletedNCT01933958

Bayer72 enrolled

Overview

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice

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

OBSERVATIONAL

Enrollment

Conditions

Gastrointestinal Stromal Tumors

Interventions

Regorafenib (Stivarga, BAY73-4506)DRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

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 Outcomes

overall survival (OS)

Time frame: Up to 3 years

time to treatment failure (TTF)

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.

Time frame: Up to 3 years

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.

Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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