Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stivarga Regulatory Post-Marketing Surveillance Study in Korea (StivargaPMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02106858
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Drug: Regorafenib (Stivarga,BAY73-4506)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
Actual Study Start Date : June 25, 2014
Estimated Primary Completion Date : May 7, 2019
Estimated Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Group/Cohort Intervention/treatment
Group 1
Patients treated by Physician with Stivarga under approved local prescriptions
Drug: Regorafenib (Stivarga,BAY73-4506)
Patients treated by Physician with Stivarga under approved local prescriptions




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106858


Contacts
Layout table for location contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com

Locations
Layout table for location information
Korea, Republic of
Recruiting
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Additional Information:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02106858     History of Changes
Other Study ID Numbers: 16778
SV1314KR ( Other Identifier: Company Internal )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Keywords provided by Bayer:
Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases