check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

16472

ClinicalTrials.gov Identifier:

NCT01843400

EudraCT Number:

Not Available

EU CT Number:

Not Available
Regorafenib post-marketing surveillance

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • Patients
    - who are determined to start Regorafenib/ STIVARGA treatment

  • - Patients who have previously received Regorafenib/ STIVARGA

Trial summary

Enrollment Goal
1301
Trial Dates
April 2013 - November 2016
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
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    Safety Issue:
    Yes
  • Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.
    date_rangeTime Frame:
    up to 6 months
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    Safety Issue:
    Yes

Secondary Outcome

  • Number of pateints with ADRs in subpopulations
    date_rangeTime Frame:
    Up to 6 months
  • Number of patients with SAEs in supopulations
    date_rangeTime Frame:
    Up to 6 months
  • Overall survival (OS)
    date_rangeTime Frame:
    Up to 12 months
  • Overall survival in subpopulations
    date_rangeTime Frame:
    Up to 12 months
  • Time to treatment failure (TTF)
    date_rangeTime Frame:
    Up to 12 months
  • Time to Treatment failure in subpopulations
    date_rangeTime Frame:
    Up to 12 months
  • Tumor response assessed by RECIST or physicians own evaluation
    RECIST: Response Evaluation Criteria In Solid Tumors
    date_rangeTime Frame:
    Up to 6 months

Trial design

Drug Use Investigation of Regorafenib/ STIVARGA for unresectable, metastatic or recurrent colorectal cancer
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

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