Safety/efficacy of Everolimus in adults with advanced pancreatic neuroendocrine cancer not responsive to chemotherapy
- Conditions
- Advanced pancreatic neuroendocrine tumors (NET).MedDRA version: 14.1Level: LLTClassification code 10033630Term: Pancreatic islet cell neoplasm malignant NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-001247-64-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
•Advanced (unresectable or metastatic) biopsy-proven pancreatic NET
•Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
•Objective disease progression by RECIST criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
•Presence of at least one measurable disease using RECIST criteria at screening (CT or MRI)
•Adequate bone marrow, liver and kidney function 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
•Patients with poorly differentiated neuroendocrine carcinoma
•Hepatic artery embolization within the last 6 months
•Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
•Other concurrent malignancy
•Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method