Sunitinib rechallenge in metastatic kidney cancer
- Conditions
- Metastatic renal cancer thrid-line therapy already treated in fist-line therapy with Sunitinib.MedDRA version: 14.1Level: LLTClassification code 10009251Term: Clear cell carcinoma of the kidneySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000473-23-IT
- Lead Sponsor
- GIOM - Gruppo Italiano Oncologia Nefrologica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Histologically proven diagnosis of Renal Cell Carcinoma with predominant clear cell component. 2. First-line treatment with Sunitinib. 3. Patients with a Disease Control Rate (Complete Response + Partial Response + Stable Disease) lasting at least 10 months from first-line Sunitinib treatment. 4. Second-line treatment with Everolimus. 5. Age higher than 18. 6. ECOG Performance Status 0-2. 7. Life expectancy of at least 8 weeks. 8. Measurable lesions according to RECIST criteria. 9. Adequate cardiac, hepatic, renal, and bone marrow function. 10. Written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. First-line treatment with other compounds (excluding Sunitinib). 2. Symptomatic and/or unstable and/or not previously treated pre-existing brain metastases. 3. Uncontrolled hypertension. 4. Severe or uncontrolled cardiovascular diseases within 6 months of study. 5. Active uncontrolled infections. 6. 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 Main Objective: To assess the antitumor activity of Sunitinib in terms of freedom from disease progression.;Secondary Objective: 1)To evaluate Sunitinib activity in terms of objective response rate 2) To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) 3) To evaluate the tolerability of Sunitinib.;Primary end point(s): Freedom from disease progression.;Timepoint(s) of evaluation of this end point: 6 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Objective response rate (CR + PR)<br>2) PFS and OS<br>3) Toxicity;Timepoint(s) of evaluation of this end point: Not applicable.