E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced non-clear Cell Renal Carcinoma. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050513 |
E.1.2 | Term | Metastatic renal cell carcinoma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038458 |
E.1.2 | Term | Renal granular cell carcinoma |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038414 |
E.1.2 | Term | Renal cell carcinoma stage IV |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Progression Free Survival (PFS) |
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E.2.2 | Secondary objectives of the trial |
Overall Response Rate (RECIST Criteria); Time to Progression (TTP); Safety; Overall Survival (OS). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signed informed consent Histologically or cytologically documented non-clear Cell Renal Carcinoma (with centralized review of histological specimens). In the case of a mixed histology the presence of a documented component of clear cell histology <50% is mandatory. Urothelial upper urinary tract tumors are excluded. In cases with initial diagnosis of non-clear RCC of more than 2 years (RFS >2 years) a histological/cytological confirmation of renal cell carcinoma origin of actual metastases is mandatory. Metastatic measurable disease (at least one uni-dimensional measurable lesion by CT-scan or MRI) according to RECIST criteria (reported in Appendix Karnofsky performance status (KPS) ≥ 70 (KPS scale reported in Appendix) Age ≥ 18 years§ Life expectancy ≥ 3 months Prior Surgery and/or Radiation Therapy (to less or equal than 25% of the bone marrow) are allowed. However, at least 4 weeks must have been elapsed since surgery or completion of radiation therapy and the patient must has recovered from side effects ANC ≥1.5 x 109/L; PLT ≥100 x 109/L; Hb ≥ 9 g/dl Adequate hepatic function: Total bilirubin ≤1.5 times UNL*; ALT and AST ≤2.5 times UNL (≤5 UNL in presence of liver metastases) Serum creatinine ≤2.0 x the UNL. Serum cholesterol ≤350 mg/dL; serum triglycerides ≤ 300 mg/dL Patients must be accessible for treatment and follow up |
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E.4 | Principal exclusion criteria |
CNS metastases Previous malignancy except for basal cell skin cancer and cervical carcinoma in situ adequately treated, or any other cancer from which the patient has been disease-free for >=5 years Any of the concomitant illness or medical condition indicated below: Serious respiratory or cardiovascular disease such as: congestive heart failure (³ NYHA Class II -refer to Appendix-); previous history (within 6 months) of myocardial infarction, angina pectoris or cardiac arrhythmias requiring anti-arrythmics (excluding beta blockers or digoxin). Active coronary artery disease, uncontrolled hypertension Unstable diabetes mellitus, significant neurological or psychiatric disorders or seizure disorder requiring medication (such as anti-epileptics). Uncontrolled hypertension (systolic pressure ³ 160 mm Hg and/or diastolic ³ 90mm Hg) while receiving chronic medication. Active clinically serious bacterial or fungal infections (> grade 2 NCI-CTC, Version 3) or active human immunodeficiency virus (HIV) infection or chronic hepatitis B or C Previous or concomitant treatment with antiangiogenic agents (e.g.: bevacizumab, sorafenib, sunitinib) or m-TOR inhibitors. Previous treatment with chemotherapy, immunotherapy (IFN and/or Interleukin-2) for advanced disease is allowed Prior isotope treatment (e.g. strontium or samarium) Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with other experimental drug Use of immunosuppressive agents including systemic steroids). History of organ allograft or autologous bone marrow transplant or stem cell rescue within four months of start of study drug Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial Known or suspected allergy to the investigational agent or any agent given in association with this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) rates in the two arms. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco piu' altro farmaco |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |