Extension study to the expanded access study of everolimus in patients with advanced neuroendocrine tumors

Extension study to the open-label, multi-center, expanded access study of everolimus in patients with advanced neuroendocrine tumors

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001099-13-DE

Enrollment

Unknown

Registered

2012-05-04

Start date

2012-05-10

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

advanced neuroendocrine tumors of gastrointestinal or lung origin MedDRA version: 18.1 Level: LLT Classification code 10062476 Term: Neuroendocrine tumor System Organ Class: 100000004864

Interventions

Trade Name: Afinitor Pharmaceutical Form: Tablet CAS Number: 159351-69-6 Current Sponsor code: RAD001 Other descriptive name: EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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. To estimate investigator-assessed progression free survival (PFS). 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. ;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	—

Measure

Time frame

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. To estimate investigator-assessed progression free survival (PFS). 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. ;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

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal or lung origin treated with everolimus. To estimate investigator-assessed progression free survival (PFS). 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. ;Timepoint(s) of evaluation of this end point: after 5 years	—

Measure

Time frame

Secondary end point(s): To evaluate investigator-assessed best overall response in patients with advanced NETs of gastrointestinal or lung origin treated with everolimus. To estimate investigator-assessed progression free survival (PFS). 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. ;Timepoint(s) of evaluation of this end point: after 5 years

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Countries

Germany

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

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