Regorafenib Post-marketing Surveillance in Japan

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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Stromal Tumors
• Intervention / Treatment: Drug: Regorafenib (Stivarga, BAY73-4506)

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: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are treated with Regorafenib/STIVARGA and meet the product label

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

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.	Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.	Up to 6 months
Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)		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.	Up to 3 years
tumour response		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)	Up to 3 years

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Komatsu Y, Doi T, Sawaki A, Kanda T, Yamada Y, Kuss I, Demetri GD, Nishida T. Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial. Int J Clin Oncol. 2015 Oct;20(5):905-12. doi: 10.1007/s10147-015-0790-y. Epub 2015 Feb 6.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2013
• Primary Completion (ACTUAL): March 29, 2021
• Study Completion (ACTUAL): October 29, 2021

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: August 29, 2013
• First Posted (ESTIMATE): September 2, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Regorafenib; Gastrointestinal stromal tumors
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: 16732; STIVARGA-GIST-01 (OTHER: company internal)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No