Extension study to the expanded access study of everolimus in patients with advanced neuroendocrine tumors
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]advanced neuroendocrine tumors of gastrointestinal or lung originMedDRA version: 18.1Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864
- Registration Number
- EUCTR2012-001099-13-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
• The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
• Age =18 years old
• Completion of the whole treatment period in the CRAD001K24133 study
• Neuroendocrine tumor of gastrointestinal or pulmonary origin (pancreatic neuroendocrine tumors are excluded)
• No tumor progression during therapy with everolimus during CRAD001K24133 study (checked via radiologically assessment)
• No intolerable toxicity during therapy everolimus, or during combination therapy of everolimus and somatostatin analogues
• Women of child-bearing potential must have a negative pregnancy test at visit E1. Only if this test is negative, the patient will receive study medication
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate long-term safety of everolimus in patients with advanced neuroendocrine tumors of gastrointestinal or pulmonary origin.;Secondary Objective: To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal or lung origin treated with everolimus.<br>To estimate investigator-assessed progression free survival (PFS).<br>To assess disease related symptoms and changes in health related quality of life (HRQoL) over time in patients with advanced neuroendocrine tumors of gastrointestinal or lung origin treated with everolimus.<br>;Primary end point(s): To evaluate long-term safety of everolimus in patients with advanced neuroendocrine tumors of gastrointestinal or pulmonary origin.;Timepoint(s) of evaluation of this end point: after 5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal or lung origin treated with everolimus.<br>To estimate investigator-assessed progression free survival (PFS).<br>To assess disease related symptoms and changes in health related quality of life (HRQoL) over time in patients with advanced neuroendocrine tumors of gastrointestinal or lung origin treated with everolimus.<br>;Timepoint(s) of evaluation of this end point: after 5 years