A multicenter, two stage, phase II study, evaluating the efficacy of oral BEZ235 plus best supportive care (BSC) versus placebo plus BSC in the treatment of patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy

OVARTIS FARMA0 个研究点目标入组 150 人开始时间: 2012年9月19日最近更新: 2016年1月18日

研究概览

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•1. Patient must have advanced (unresectable or metastatic), histologically confirmed low or intermediate grade pancreatic pNET according to the WHO 2010 classification (grade 1 or 2) and show radiological evidence of disease progression since last treatment. 2. Patients’ disease is refractory to treatment with mTOR inhibitor. Patients must not have taken another treatment between mTOR inhibitor and BEZ235. NOTE: Refractory is defined as progression while on treatment or within 3 months of treatment discontinuation. 3. Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). 4. Prior or concurrent therapy with SSA is permitted; however, for concurrent therapy with SSA while on study, patients must be on a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment. 5. Adequate bone marrow function or organ function. 6. WHO PS = 1. 7. Adult male or female patients = 18 years of age.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Patient has received previous treatment with any PI3K inhibitor or AKT inhibitor for the treatment of pNET. 2. Patient has discontinued prior mTOR inhibitor therapy due to toxicity. 3. Patient has poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma. 4. Patient has been treated with hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment. 5. Patients with more than 3 prior systemic treatment regimens. 6. Patient who has any severe and/or uncontrolled medical conditions. 7. Patient has any cardiac abnormalities. 8. Patient has impairment of GI function or GI disease that may significantly alter the absorption of study drug.

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