Stivarga Regulatory Post-Marketing Surveillance Study in... | NCT02106858

Studies
Stivarga Regulatory Post-Marketing Surveillance Study in Korea

NCT02106858

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 24, 2023Actual

Enrollment

316Actual

Phase

Not provided

Conditions

Colorectal Neoplasms

Interventions

Regorafenib (Stivarga,BAY73-4506)

Countries

South Korea

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
SV1314KR	Other Identifier	Company Internal

Status Module

Record Verification Date

Jul 2023

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

Jun 25, 2014Actual

Primary Completion Date

May 7, 2019Actual

Completion Date

May 7, 2019Actual

First Submitted Date

Apr 4, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 8, 2014Estimated

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

Jul 20, 2023

Last Update Posted Date

Jul 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

316Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Patients treated by Physician with Stivarga under approved local prescriptions	Drug: Regorafenib (Stivarga,BAY73-4506)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib (Stivarga,BAY73-4506)	Drug	Patients treated by Physician with Stivarga under approved local prescriptions	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with serious adverse events	Every 2 months (monthly safety assessment within first two cycles)	Up to 30 days after terminating treatment
Percentage of patients with adverse drug reactions (ADRs)	Every 2 months (monthly safety assessment within first two cycles)	Up to 30 days after terminating treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall response		Up to 6 years
Progression free survival (PFS)		Up to 6 years
Overall survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:
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
Exclusion Criteria:
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.

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 diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D009362	Neoplasm Metastasis
D046152	Gastrointestinal Stromal Tumors

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