Sunitinib in Metastatic Renal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01034878
First received: December 17, 2009
Last updated: September 1, 2010
Last verified: September 2010
  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
Metastatic Renal Cancer With Non-clear Cell
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 55
Study Start Date: December 2009
Estimated Study Completion Date: November 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  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

Contacts
Contact: Armando Santoro, MD +39028224 ext 4080 armando.santoro@humanitas.it
Contact: Andrea Zucali, MD +39028224 ext 4080 andrea.zucali@humanitas.it

Locations
Italy
Istituto Clinco Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Armando Santoro, MD    +30028224 ext 4080    armando.santoro@humanitas.it   
Contact: Andrea Zucali, MD    +30028224 ext 4080    andrea.zucali@humanitas.it   
Sub-Investigator: Andrea Zucali, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, 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: September 1, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014