E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with neuroendocrine tumours |
|
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 | 10057270 |
E.1.2 | Term | Neuroendocrine carcinoma |
|
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 |
|
E.2.2 | Secondary objectives of the trial |
The time to progression (TTP) and overall survival (OS). The symptomatic responses. The biochemical responses. The safety and tollerability |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histological diagnosis of well differentiated endocrine carcinoma or histological diagnosis of typical and atypical carcinoid of the lung - Ki-67 &#8804; 2%. - Metastatic or locally advanced disease - Adult male or female patients &#8805;18 years of age - Patients with or without carcinoid syndrome - Adequate renal function: serum creatinine &#8804;1.5 x ULN - Adequate liver function as shown by: serum bilirubin &#8804;1.5 x ULN; ALT and AST <= 2.5x ULN (<= 5x ULN in patients with liver metastases) - Adequate bone marrow function: ANC >= 1.5 x 109/L;PLT >= 100 x 109/L; Hb > 9 g/dL - ECOG performance status 0-1 - Life expectancy >6 months - At least one measurable lesion at CT scan as defined by RECIST - Women of childbearing potential must have had a negative serum or urine pregnancy test within 7 days prior to the administration of the study treatment start, and must use an acceptable form of contraception. - Patients who give a written informed consent |
|
E.4 | Principal exclusion criteria |
- Patients who received prior therapy with somatostatin analogues, RAD001 or other rapamycins - Patients who received a prior anticancer therapy for neuroendocrine tumor - Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients - Histological diagnosis of poorly differentiated endocrine carcinoma - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction &#8804; 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function; uncontrolled diabetes; any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study; non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment, such as severe hypertension that is not controlled with medical management and thyroid abnormalities due to which thyroid function cannot be maintained in the normal range by medication; liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis or chronic persistent hepatitis; fatal or life-threatening autoimmune and ischemic disorders; uncontrolled hyperlipidemia - Patients with serious neurological or psychiatric disorders - Patients with central nervous system (CNS) metastases - Patients who have a history of another primary malignancy with the exception of basal or squamous cell skin cancer, in situ cancer, and any cancer from which the patient has been disease free for 5 years - Immunocompromised patients, including positive HIV test. An HIV test is not required to enter the study - Patients on concomitant medications known to inhibit, induce or be a substrate of CYP3A isoenzyme - Female patients who are pregnant or breast feeding - Patients of reproductivepotential who are not using appropriate contraceptive methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not accetable |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
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 | No |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 16 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |