Advanced/metastatic NCCRC MedDRA version: 9.1 Level: SOC Classification code 10038359 MedDRA version: 9.1 Level: SOC Classification code 10029104
Conditions
Interventions
Trade Name: SUTENT
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: SUNITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy
Outcome results
None listed