Sunitinib in Metastatic Renal Cancer | NCT01034878

Studies
Sunitinib in Metastatic Renal Cancer

NCT01034878

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Dec 23, 2014Estimated

Enrollment

25Actual

Phase

Phase 2

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Countries

Italy

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

Dec 2014

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

Dec 2009

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 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

Dec 22, 2014

Last Update Posted Date

Dec 23, 2014Estimated

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

Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

Detailed Description

This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.

Treatment with the study drug will continue until tumor progression or unacceptable toxicity.

The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sunitinib	Experimental	50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off	Drug: Sunitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunitinib	Drug	Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The antitumor activity in terms of progression free survival		two years

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the objective response rate		two years
To evaluate the toxicity and the safety profile		two years
To evaluate the overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven diagnosis of metastatic renal cancer with non-clear cell
No previous treatment

Exclusion Criteria:

Prior treatment with an antiangiogenetic compound
Symptomatic and/or unstable pre-existing brain metastases
Severe or uncontrolled cardiovascular diseases

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Santoro, MD	Istituto Clinico Humanitas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinco Humanitas		Rozzano	Milano	20089	Italy

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
D000077210	Sunitinib

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided