Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)
- Conditions
- Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 14.1 Level: LLT Classification code 10068916 Term: Pancreatic neuroendocrine tumor metastatic System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000675-16-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 31
-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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-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
-Radiotherapy, or major surgery within 4 weeks prior to study treatment start
-Hepatic artery embolization or cryoablation/radiofrequency ablation of hepatic metastasis within 3 months of enrolment
-More than 3 prior systemic treatment regimens,
-Other protocol defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the efficacy of BEZ235 in adult patients with advanced (unresectable or metastatic) pNET (PFS);<br> Secondary Objective: To assess the safety and tolerability of BEZ235 therapy<br> To evaluate the efficacy of BEZ235 per modified RECIST v1.1 (Overall Response Rate, Disease Control Rate, Duration of Response )<br> ;Primary end point(s): PFS rate at 16 weeks according to local radiological assessment per modified RECIST v1.1;Timepoint(s) of evaluation of this end point: up to approx 18 months
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Frequency and severity of adverse events;other safety data as considered appropriate<br> Overall Response Rate, Disease Control Rate, Duration of Response )<br> ;Timepoint(s) of evaluation of this end point: up to approx. 18 months for all secondary endpoint