Sunitinib in Metastatic Renal Cancer

Carcinoma, Renal Cell Clinical Trial

Official title:

Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034878
• Other study ID #: ONC-2008-004
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2009
• Last updated: December 22, 2014
• Start date: December 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• Sunitinib
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.

Locations

Country	Name	City	State
Italy	Istituto Clinco Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The antitumor activity in terms of progression free survival		two years	No
Secondary	To evaluate the objective response rate		two years	No
Secondary	To evaluate the toxicity and the safety profile		two years	No
Secondary	To evaluate the overall survival		two years	No