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

Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000769-19-GB

Enrollment

140

Registered

2012-08-09

Start date

2012-09-24

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patient in advanced pancreatic neuroendocrine tumors MedDRA version: 20.0 Level: LLT Classification code 10068916 Term: Pancreatic neuroendocrine tumor metastatic System Organ Class: 100000004864

Interventions

Product Name: BEZ235 Product Code: BEZ235 Pharmaceutical Form: Powder for oral suspension CAS Number: 1028385-32-1 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 To estimate the objective response rate of BEZ235 and everolimus To estimate overall survival of BEZ235 and everolimus 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	—

Measure

Time frame

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 To estimate the objective response rate of BEZ235 and everolimus To estimate overall survival of BEZ235 and everolimus 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

Measure	Time frame
Secondary end point(s): Frequency and severity of adverse events;other safety data as considered appropriate Objective Response Rate (best overall response) Overall survival 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	—

Countries

Australia, Brazil, France, Italy, Korea, Republic of, Netherlands, New Zealand, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma Services AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026