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-AT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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

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
- Radiotherapy, or major surgery within 4 weeks prior to study treatment start
- Hepatic artery embolization 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