A randomized, double-blind placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10 mg/Day or Sandostatin LAR and Placebo
- Conditions
- Carcinoid10052547
- Registration Number
- NL-OMON37069
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
1. Advanced (unresectable or metastatic) biopsy-proven carcinoid tumor.
2. Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
3. Radiological documentation of progression of disease within 12 months prior to randomization
4. Measurable disease CTscan or MRI
5. Adequate bone marrow function (ANC * 1.5 x 109/L, Platelets * 100 x 109/L, Hb >9 g/dL)
6. Adequate liver function:
* serum bilirubin * 1.5 x ULN
* INR < 1.3 x ULN (or < 3 on anticoagulants)
* ALT and AST * 2.5x ULN (* 5x ULN in patients with liver metastases)
7. Adequate renal function: serum creatinine * 1.5 x ULN
8. Fasting serum cholesterol *300 mg/dL OR 7.75 mmol/L AND fasting triglycerides * 2.5 x ULN. Treatment with lipid lowering agents is allowed.
9. WHO performance 0-2
1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine
carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
2. Cytotoxic chemotherapy, immunotherapy or radiotherapy < 4 weeks prior to randomization
3. Received treatment with Sandostatin LAR® Depot or any other long-acting somatostatin
analog < 2 weeks prior to randomization.
4. Hepatic artery embolization < the last 6 months (1 month if there are other sites of
measurable disease), or cryoablation of hepatic metastasis < 2 months of randomization
5. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus)
6. Uncontrolled diabetes mellitus (fasting serum glucose >1.5 X ULN)
7. Severe and/or uncontrolled medical conditions such as:
* unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
* 6 months prior to randomization, serious cardiac arrhythmia,
* severe infection
* cirrhosis, chronic (active) hepatitis
* severely impaired lung function
8. Chronic treatment with corticosteroids or another immunosuppressive agent
9. Patients with a known history of HIV seropositivity
10. Patients with an active, bleeding diathesis
11. History of another primary malignancy * 3 years, except non-melanoma skin cancer, and carcinoma in situ of uterine cervix
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to compare the progression-free survival (based on the<br /><br>central radiological assessment). The primary efficacy variable<br /><br>progression-free survival will be analyzed using both Intention to Treat (ITT)<br /><br>and per protocol population. The analysis result of the ITT population using<br /><br>the central radiological assessment is considered as the primary analysis. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy variables include best overall response rate, the duration<br /><br>of overall response (CR or PR) and of overall complete response (CR), overall<br /><br>survival and otherefficacy markers. Best overall response rate will be assessed<br /><br>by RECIST criteria.</p><br>