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Completed

NCT Number: NCT02106858

Stivarga Regulatory Post-Marketing Surveillance Study in Korea

To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.

Completed

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, South Korea

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Signed and dated informed consent
  • Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
  • Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
  • Exclusion Criteria:
  • Patients participating in an investigational program with interventions outside of routine clinical practice
  • All contra-indications according to the local marketing authorization have to be considered.

Treatment and study plan

Regorafenib (Stivarga,BAY73-4506)

Drug

Patients treated by Physician with Stivarga under approved local prescriptions

Primary outcomes

  1. Percentage of patients with serious adverse events

    Time frame: Up to 30 days after terminating treatment

    Every 2 months (monthly safety assessment within first two cycles)

  2. Percentage of patients with adverse drug reactions (ADRs)

    Time frame: Up to 30 days after terminating treatment

    Every 2 months (monthly safety assessment within first two cycles)

Secondary outcomes

  1. Overall response

    Time frame: Up to 6 years

  2. Progression free survival (PFS)

    Time frame: Up to 6 years

  3. Overall survival (OS)

    Time frame: Up to 6 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Stivarga® Regulatory Post-Marketing Surveillance Study in Korea

Acronym: StivargaPMS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2014
Registry last updated
Jul 24, 2023

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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