Study In Patients With Kidney Cancer Treated With Sutent | NCT00873210

Studies
Study In Patients With Kidney Cancer Treated With Sutent

NCT00873210

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 9, 2012Estimated

Enrollment

121Actual

Phase

Not provided

Conditions

Advanced or Metastatic Renal Cell Carcinoma
Renal Cancer

Interventions

Sutent

Countries

Slovakia

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

Nov 2012

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

May 2009

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Apr 1, 2009Estimated

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

Nov 7, 2012

Last Update Posted Date

Nov 9, 2012Estimated

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

Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.

Detailed Description

Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

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

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with Sutent		125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy	Drug: Sutent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sutent	Drug	50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause	Patients treated with Sutent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increased knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib		36 months

Secondary Outcomes

Measure	Description	Time Frame
Dose modifications		36 months
Incidence of new diagnosed hypertension		36 months
Incidence of new diagnosed hypothyroidism

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy

Exclusion Criteria:

Hypersensitivity to sunitinib malate or to any of the excipients
Any other contraindication to the use of sunitinib malate (based on decision of the treating physician).

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

Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Banská Bystrica		975 17	Slovakia
Pfizer Investigational Site

References Module

Citations

Not provided

ID	Term
D002292	Carcinoma, Renal Cell
D007680	Kidney Neoplasms

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

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds