Regorafenib Post-marketing Surveillance

Colorectal Neoplasms Clinical Trial

Official title:

Drug Use Investigation of Regorafenib/ STIVARGA for Unresectable, Metastatic or Recurrent Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843400
• Other study ID #: 16472
• Secondary ID: STIVARGA-CRC-01
• Status: Completed
• Start date: April 22, 2013
• Est. completion date: November 14, 2016

Study information

• Verified date: July 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1301
• Est. completion date: November 14, 2016
• Est. primary completion date: September 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:Patients

• who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

• Patients who have previously received Regorafenib/ STIVARGA

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Patients treated with Regorafenib under practical manner for colorectal cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib		Up to 6 months
Primary	Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.		up to 6 months
Secondary	Number of pateints with ADRs in subpopulations		Up to 6 months
Secondary	Number of patients with SAEs in supopulations		Up to 6 months
Secondary	Overall survival (OS)		Up to 12 months
Secondary	Overall survival in subpopulations		Up to 12 months
Secondary	Time to treatment failure (TTF)		Up to 12 months
Secondary	Time to Treatment failure in subpopulations		Up to 12 months
Secondary	Tumor response assessed by RECIST or physicians own evaluation	RECIST: Response Evaluation Criteria In Solid Tumors	Up to 6 months

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