PHASE II STUDY OF SUNITINIB IN METASTATIC RENAL CANCER WITH NON-CLEAR CELL HISTOLOGY - ONC-2008-004

• Conditions: Advanced/metastatic NCCRC; MedDRA version: 9.1Level: SOCClassification code 10038359; MedDRA version: 9.1Level: SOCClassification code 10029104

• Registration Number: EUCTR2009-010672-16-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-24
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven diagnosis of NCCRC (papillary or cromophobe), confirmed by a central review of an expert pathologist. No previous treatment. Age superior to 18 years. ECOG Performance Status 0-2. Life expectancy of at least 12 weeks. Measurable lesions according to RECIST criteria. Adequate cardiac, hepatic, renal, and bone marrow function. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior treatment with an antiangiogenetic compound. Symptomatic and/or unstable pre-existing brain metastases. Uncontrolled hypertension. Severe or uncontrolled cardiovascular diseases (congestive heart failure, myocardial infarction) within 6 months of study. Active uncontrolled infections. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate the objective response rate (RR); To evaluate the toxicity and the safety profile; To evaluate the overall survival (OS).;Primary end point(s): To assess the antitumor activity in terms of progression free survival (PFS);Main Objective: To assess the antitumor activity in terms of progression free survival (PFS)