Extension Study to the "Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study"
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors
Both
Neuroendocrine Tumors
Trial Information
Extension Study to the "Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study"
Inclusion Criteria
Inclusion and Exclusion Criteria:
Patients eligible for inclusion in this extension study have to meet all of the additional
inclusion criteria:
- The patient must provide a signed Informed Consent Form (ICF) for the extension study
prior to any study related procedures
- Completion of the whole treatment period of 15 months (3 months monotherapy with
either pasireotide LAR or everolimus followed by a 12 months combination of
pasireotide LAR/everolimus) in the CSOM230F2102 study
- No tumor progression during 12 months of combination therapy with pasireotide LAR and
everolimus (checked via radiologically assessment).
No intolerable toxicity during combination therapy with pasireotide LAR and everolimus
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
Outcome Time Frame:
up to 4 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:
CRAD001KDE47
NCT ID:
NCT01590199
Start Date:
May 2012
Completion Date:
April 2016
Related Keywords:
- Neuroendocrine Tumors
- Neuroendocrine Tumors
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