Safety and efficacy of BEZ235 in patients with pancreatic neuroendocrine tumors (pNET)
- Conditions
- Adult patient in advanced pancreatic neuroendocrine tumorsMedDRA version: 14.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000675-16-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. Patient must have advanced (unresectable or metastatic), histologically confirmed low or intermediate grade pancreatic pNET according to the WHO 2010 classification (grade 1 or 2) and show radiological evidence of disease progression since last treatment. 2. Patients’ disease is refractory to treatment with mTOR inhibitor. Patients must not have taken another treatment between mTOR inhibitor and BEZ235. NOTE: Refractory is defined as progression while on treatment or within 3 months of treatment discontinuation. 3. Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). 4. Prior or concurrent therapy with SSA is permitted; however, for concurrent therapy with SSA while on study, patients must be on a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment. 5. Adequate bone marrow function or organ function. 6. WHO PS = 1. 7. Adult male or female patients = 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
1. Patient has received previous treatment with any PI3K inhibitor or AKT inhibitor for the treatment of pNET. 2. Patient has discontinued prior mTOR inhibitor therapy due to toxicity. 3. Patient has poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma. 4. Patient has been treated with 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. 5. Patients with more than 3 prior systemic treatment regimens. 6. Patient who has any severe and/or uncontrolled medical conditions. 7. Patient has any cardiac abnormalities. 8. Patient has impairment of GI function or GI disease that may significantly alter the absorption of study drug.
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;Secondary Objective: To assess the safety and tolerability of BEZ235 therapy To evaluate the efficacy of BEZ235 per modified RECIST v.1.1.;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. 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