Regorafenib Post-marketing Surveillance in Japan

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Drug Use Investigation of Regorafenib/ STIVARGA for Gastrointestinal Stromal Tumor Progressed After Cancer Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933958
• Other study ID #: 16732
• Secondary ID: STIVARGA-GIST-01
• Status: Completed
• Start date: September 4, 2013
• Est. completion date: October 29, 2021

Study information

• Verified date: March 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 29, 2021
• Est. primary completion date: March 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.		Up to 6 months
Primary	Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.		Up to 6 months
Primary	Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib		up to 6 months
Secondary	overall survival (OS)		Up to 3 years
Secondary	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.	Up to 3 years
Secondary	tumour response		Up to 3 years
Secondary	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)	Up to 3 years