check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

16778

ClinicalTrials.gov Identifier:

NCT02106858

EudraCT Number:

Not Available

EU CT Number:

Not Available
Stivarga Regulatory Post-Marketing Surveillance Study in Korea

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - :
    - 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

    -
  • - 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.

Trial summary

Enrollment Goal
316
Trial Dates
June 2014 - May 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Percentage of patients with serious adverse events
    Every 2 months (monthly safety assessment within first two cycles)
    date_rangeTime Frame:
    Up to 30 days after terminating treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of patients with adverse drug reactions (ADRs)
    Every 2 months (monthly safety assessment within first two cycles)
    date_rangeTime Frame:
    Up to 30 days after terminating treatment
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Overall response
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Progression free survival (PFS)
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    date_rangeTime Frame:
    Up to 6 years
    enhanced_encryption
    Safety Issue:
    No

Trial design

Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products