Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)

Conditions: Adult patient in advanced pancreatic neuroendocrine tumors
MedDRA version: 14.1Level: LLTClassification code 10068916Term: Pancreatic neuroendocrine tumor metastaticSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000675-16-ES

Lead Sponsor: ovartis Farmaceutica S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

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

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);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 );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
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 );Timepoint(s) of evaluation of this end point: up to approx. 18 months for all secondary endpoint