An open label, single arm, phase II study of combination RAD001 and octreotide LAR in patients with advanced neuroendocrine tumors as first line treatment - RAD001 and NETs, first line treatment
- Conditions
- Patients with neuroendocrine tumoursMedDRA version: 9.1Level: LLTClassification code 10057270Term: Neuroendocrine carcinoma
- Registration Number
- EUCTR2008-007153-13-IT
- Lead Sponsor
- I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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 <= 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
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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective responses;Secondary Objective: The time to progression (TTP) and overall survival (OS). <br>The symptomatic responses. <br>The biochemical responses. <br>The safety and tollerability;Primary end point(s): Response rate
- Secondary Outcome Measures
Name Time Method