Regorafenib Post-marketing Surveillance | NCT01843400

Studies
Regorafenib Post-marketing Surveillance

NCT01843400

Sponsor

Bayer

Status

Completed

Last Update Posted

Aug 2, 2018Actual

Enrollment

1,301Actual

Phase

Not provided

Conditions

Colorectal Neoplasms

Interventions

Regorafenib (Stivarga, BAY73-4506)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
STIVARGA-CRC-01	Other Identifier	company internal

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2013Actual

Primary Completion Date

Sep 12, 2016Actual

Completion Date

Nov 14, 2016Actual

First Submitted Date

Apr 26, 2013

First Submission Date that Met QC Criteria

Apr 26, 2013

First Posted Date

Apr 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2018

Last Update Posted Date

Aug 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,301Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib (Stivarga, BAY73-4506)	Drug	Patients treated with Regorafenib under practical manner for colorectal cancer.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib		Up to 6 months
Number of patients with serious adverse events(SAEs) from the first administration of regorafenib.		up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of pateints with ADRs in subpopulations		Up to 6 months
Number of patients with SAEs in supopulations		Up to 6 months
Overall survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Patients

who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

Patients who have previously received Regorafenib/ STIVARGA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with unresectable, metastatic or recurrent colorectal cancer

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C559147	regorafenib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided