Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01886287
Status:
TERMINATED
Last Update Posted:
2015-01-12
First Post:
2013-06-21
Brief Title:
PII Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Above-Label Octreotide-LAR in Patients With Insufficiently Controlled Carcinoid Syndrome
Status:
TERMINATED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to investigate the effects of high-dose octreotide on flushing diarrhea and quality of life in patients whose disease-related symptoms are inadequately controlled by the maximum approved dose of octreotide LAR
Detailed Description:
The study population will consist of patients with advanced metastatic or unresectable neuroendocrine tumors with suboptimally controlled carcinoid syndrome While the majority of patients will have primary tumors of the ileocecum midgut any serotonin-producing neuroendocrine tumors will be eligible including pancreatic lung and unknown primary
All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide or until resolution or stabilization of the event whichever comes first
All patients will be followed for adverse events and serious adverse events for 28 days following the last dose of above-label octreotide or until resolution or stabilization of the event whichever comes first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CSMS995AUS64T | OTHER | Novartis | None |