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Sunitinib in Metastatic Renal Cancer

This study has been completed.
Information provided by (Responsible Party):
Istituto Clinico Humanitas Identifier:
First received: December 17, 2009
Last updated: December 22, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology

Resource links provided by NLM:

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • The antitumor activity in terms of progression free survival [ Time Frame: two years ]

Secondary Outcome Measures:
  • To evaluate the objective response rate [ Time Frame: two years ]
  • To evaluate the toxicity and the safety profile [ Time Frame: two years ]
  • To evaluate the overall survival [ Time Frame: two years ]

Enrollment: 25
Study Start Date: December 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunitinib
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
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.
Other Name: Sutent

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01034878

Istituto Clinco Humanitas
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Responsible Party: Istituto Clinico Humanitas Identifier: NCT01034878     History of Changes
Other Study ID Numbers: ONC-2008-004
Study First Received: December 17, 2009
Last Updated: December 22, 2014

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on May 25, 2017