Sunitinib in Metastatic Renal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01034878
First received: December 17, 2009
Last updated: December 22, 2014
Last verified: December 2014
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the objective response rate [ Time Frame: two years ] [ Designated as safety issue: No ]
  • To evaluate the toxicity and the safety profile [ Time Frame: two years ] [ Designated as safety issue: No ]
  • To evaluate the overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034878

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

No publications provided

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

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015