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: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000769-19-ES
• Lead Sponsor: ovartis Farmacéutica, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified