Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors
Phase 4
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors
Both
Neuroendocrine Tumors
Trial Information
Extension Study to the Open-label, Multi-center, Expanded Access Study of Everolimus in Patients With Advanced Neuroendocrine Tumors
Inclusion Criteria
Inclusion and Exclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability
Outcome Time Frame:
up to 2 years
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CRAD001K24133E1
NCT ID:
NCT01595009
Start Date:
June 2012
Completion Date:
June 2014
Related Keywords:
- Neuroendocrine Tumors
- Neuroendocrine Tumors
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