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Completed

NCT Number: NCT01843400

Regorafenib Post-marketing Surveillance

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 colorectal cancer.

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

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients

  • who are determined to start Regorafenib/ STIVARGA treatment

Exclusion criteria

  • Patients who have previously received Regorafenib/ STIVARGA

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

Patients treated with Regorafenib under practical manner for colorectal cancer.

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

Secondary outcomes

  1. Number of pateints with ADRs in subpopulations

    Time frame: Up to 6 months

  2. Number of patients with SAEs in supopulations

    Time frame: Up to 6 months

  3. Overall survival (OS)

    Time frame: Up to 12 months

  4. Overall survival in subpopulations

    Time frame: Up to 12 months

  5. Time to treatment failure (TTF)

    Time frame: Up to 12 months

  6. Time to Treatment failure in subpopulations

    Time frame: Up to 12 months

  7. Tumor response assessed by RECIST or physicians own evaluation

    Time frame: Up to 6 months

    RECIST: Response Evaluation Criteria In Solid Tumors

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2013
Registry last updated
Aug 2, 2018

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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