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 Pharma Services AG0 个研究点目标入组 150 人开始时间: 2012年8月10日最近更新: 2015年7月10日

适应症

试验速览

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•Inclusion Criteria: Unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine
•tumor with radiological evidence of disease progression since last treatment. Refractory disease to treatment with mTOR
•inhibitor, Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging
•(MRI), Prior or concurrent therapy with SSA is permitted;a stable dose at least 2 months prior to study start and must
•continue on the stable dose while receiving study treatment; Other protocol defined inclusion/exclusion criteria may apply.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Exclusion Criteria: Previous treatment with any PI3K or AKT inhibitor, Discontinuation prior mTOR inhibitor therapy due to
•toxicity, Poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell
•carcinoid and small cell carcinoma, Cytotoxic chemotherapy, targeted therapy, immunotherapy, radiotherapy, or major
•surgery within 4 weeks prior to enrolment in the study, 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 More than 3 prior systemic treatment regimens, Other protocol defined inclusion/exclusion criteria may apply

发起方