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Completed

NCT Number: NCT01933958

Regorafenib Post-marketing Surveillance in Japan

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

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.

    Time frame: Up to 6 months

  2. Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.

    Time frame: Up to 6 months

  3. Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib

    Time frame: up to 6 months

Secondary outcomes

  1. overall survival (OS)

    Time frame: Up to 3 years

  2. 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.

  3. tumour response

    Time frame: Up to 3 years

  4. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2013
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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