Back to resultsSunitinib in Metastatic Renal Cancer
Primary Purpose
Carcinoma, Renal Cell
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell
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
Sites / Locations
- Istituto Clinco Humanitas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sunitinib
Arm Description
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
Outcomes
Primary Outcome Measures
The antitumor activity in terms of progression free survival
Secondary Outcome Measures
To evaluate the objective response rate
To evaluate the toxicity and the safety profile
To evaluate the overall survival
Full Information
NCT ID
NCT01034878
First Posted
December 17, 2009
Last Updated
December 22, 2014
Sponsor
Istituto Clinico Humanitas
1. Study Identification
Unique Protocol Identification Number
NCT01034878
Brief Title
Sunitinib in Metastatic Renal Cancer
Official Title
Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunitinib
Arm Type
Experimental
Arm Description
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
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.
Primary Outcome Measure Information:
Title
The antitumor activity in terms of progression free survival
Time Frame
two years
Secondary Outcome Measure Information:
Title
To evaluate the objective response rate
Time Frame
two years
Title
To evaluate the toxicity and the safety profile
Time Frame
two years
Title
To evaluate the overall survival
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Santoro, MD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Clinco Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
12. IPD Sharing Statement
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Sunitinib in Metastatic Renal Cancer
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