Patients with neuroendocrine tumours MedDRA version: 9.1 Level: LLT Classification code 10057270 Term: Neuroendocrine carcinoma
Conditions
Interventions
Product Name: EVEROLIMUS
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharma
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological diagnosis of well differentiated endocrine carcinoma or histological diagnosis of typical and atypical carcinoid of the lung - Ki-67 ≤ 2%. - Metastatic or locally advanced disease - Adult male or female patients ≥18 years of age - Patients with or without carcinoid syndrome - Adequate renal function: serum creatinine ≤1.5 x ULN - Adequate liver function as shown by: serum bilirubin ≤1.5 x ULN; ALT and AST = 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 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: - 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 ≤ 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective responses;Secondary Objective: The time to progression (TTP) and overall survival (OS). The symptomatic responses. The biochemical responses. The safety and tollerability;Primary end point(s): Response rate | — |
Countries
Italy
Outcome results
None listed