check_circleStudy Completed

Gastrointestinal stromal tumors

Bayer Identifier:

16732

ClinicalTrials.gov Identifier:

NCT01933958

EudraCT Number:

Not Available

EU CT Number:

Not Available
Regorafenib post-marketing surveillance in Japan

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who are treated with Regorafenib/ STIVARGA and meet the product label.
  • - Patients who are treated with Regorafenib/ STIVARGA and don’t meet the product label.

Trial summary

Enrollment Goal
72
Trial Dates
September 2013 - October 2021
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of Patients with serious adverse drug reactions (SADRs) from the first administration of Regorafenib
    date_rangeTime Frame:
    up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • overall survival (OS)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • time to treatment failure (TTF)
    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.
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • tumour response
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Integration analysis for safety in drug use investigations (DUIs) for both colorectal cancer and gastrointestinal stromal tumor.
    Integration analysis including incidence and risk factor of adverse drug reaction (ADR), serious adverse event (SAE) and serious adverse drug reaction (SADR)
    date_rangeTime Frame:
    Up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Drug Use Investigation of Regorafenib/ STIVARGA for gastrointestinal stromal tumor progressed after cancer chemotherapy
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A