Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)
- Conditions
- Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 15.0Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000769-19-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor - Progressive disease within the last 12 months - Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT Other protocol-defined inclusion 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 40
Exclusion Criteria: - Prior treatment with mTOR or PI3K inhibitors -Patients with more than 2 prior systemic treatment regimens - Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks 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 assess the treatment effect of BEZ235 relative to everolimus on progression free survival in patients with advanced pancreatic neuroendocrine tumors who have not been previously treated with an mTOR inhibitor.;Secondary Objective: To determine the safety and tolerability of BEZ235 and everolimus<br>To estimate the objective response rate of BEZ235 and everolimus<br>To estimate overall survival of BEZ235 and everolimus<br>To estimate time to treatment failure of BEZ235 and everolimus;Primary end point(s): Progression free survival based on investigator assessment;Timepoint(s) of evaluation of this end point: up to approx 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Frequency and severity of adverse events;other safety data as considered appropriate<br>Objective Response Rate (best overall response)<br>Overall survival<br>Time to treatment failure;Timepoint(s) of evaluation of this end point: up to approx. 18 months for all secondary endpoint except for overall survival up to approx 30 months