Nexavar Dosing in Renal Cancer Patients in "Real-life" Se... | NCT01557127

Studies
Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting

NCT01557127

Sponsor

Bayer

Status

Completed

Last Update Posted

Mar 28, 2017Actual

Enrollment

205Actual

Phase

Not provided

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib (Nexavar, BAY43-9006)

Countries

Poland

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

Status Module

Record Verification Date

Mar 2017

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

Nov 1, 2011Actual

Primary Completion Date

May 16, 2014Actual

Completion Date

Mar 31, 2016Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 16, 2012

First Posted Date

Mar 19, 2012Estimated

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

Mar 24, 2017

Last Update Posted Date

Mar 28, 2017Actual

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 registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.

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

205Actual

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 scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients in whom the actual dose of sorafenib equaled the planned dose		12 months

Secondary Outcomes

Measure	Description	Time Frame
Overall tolerability of treatment as measured by rate of adverse events		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >/= 18 years
Diagnosis of renal cell carcinoma
Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
Patients in whom the oncologist has decide to start therapy with sorafenib.

Exclusion Criteria:

Synonymous with contraindications to Nexavar.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with renal cell carcinoma scheduled to treatment with sorafenib, following therapy failure with IFN/IL-2

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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