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 - RAD001 and Sandostatin LAR in patients with advanced carcinoid tumor

ovartis0 个研究点目标入组 9 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•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

发起方