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Sunitinib in Metastatic Renal Cancer

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ClinicalTrials.gov Identifier: NCT01034878
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Sunitinib Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology
Study Start Date : December 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01034878     History of Changes
Other Study ID Numbers: ONC-2008-004
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

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