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NCT Number: NCT01034878

Sunitinib in Metastatic Renal Cancer

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.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Clinco Humanitas

Rozzano, Milano, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunitinib

Drug

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 names: Sutent

Primary outcomes

  1. The antitumor activity in terms of progression free survival

    Time frame: two years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 18, 2009
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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