Nexavar Post-marketing Surveillance for RCC in Japan: Ear... | NCT01412671

Studies
Nexavar Post-marketing Surveillance for RCC in Japan: Early Access Program

NCT01412671

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 6, 2018Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib (Nexavar, BAY43-9006)

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
NEXAVAR-RCC-01	Other Identifier	Company Internal

Status Module

Record Verification Date

Jun 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

Feb 27, 2008Actual

Primary Completion Date

Sep 21, 2011Actual

Completion Date

Feb 28, 2016Actual

First Submitted Date

Aug 7, 2011

First Submission Date that Met QC Criteria

Aug 7, 2011

First Posted Date

Aug 9, 2011Estimated

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

Jun 4, 2018

Last Update Posted Date

Jun 6, 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 an early access program of 'Nexavar post-marketing surveillance (PMS) for renal cell carcinoma (RCC) in Japan' which is a regulatory, local prospective and observational study for patients with unresectable or advanced RCC under real-life practice conditions. The objective of this study is to assess safety and effectiveness of Nexavar at some limited sites which joined to clinical trial of Nexavar, before available of it in the market. The enrollment period is 2 months, and patients who received Nexavar will be recruited and followed one year since starting Nexavar administration. The data of this study will be integrated into the Nexavar PMS and the data will not be analyzed and reported alone.

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

Not provided

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

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib (Nexavar, BAY43-9006)	Drug	Patients who have received Nexavar for unresectable or advanced RCC.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar		After Nexavar administration, up to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease, clinical staging of RCC, Eastern Cooperative Oncology Group-Performance Status (ECOG-PS)]		After Nexavar administration, up to 1 year
Effectiveness evaluation assessment [overall survival, response rate, stable disease rate, progression disease rate] by investigator-determined overall best response [according to the General rule for clinical and pathological studies on RCC]

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received Nexavar for unresectable or advanced renal cell carcinoma

Exclusion Criteria:

Patients who are contraindicated based on the product label

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

The target population of this study is patients who received Nexavar for unresectable or advanced RCC.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided