Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363051
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2006-08-02
Brief Title:
SafetyEfficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open Label Stratified Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor NET After Failure of Cytotoxic Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor NET not responsive to cytotoxic chemotherapy All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors RECIST or until unacceptable toxicity occurred or until the patient or investigator requested discontinuation of treatment
Detailed Description:
This was a stratified two-stage single-arm phase 2 study of treatment with everolimus in patients with advanced unresectable or metastatic pancreatic neuroendocrine tumor NET after failure of cytotoxic chemotherapy
Stratum 1 consisted of patients not receiving chronic Octreotide Depot therapy will receive everolimus monotherapy at 10 mgday
Stratum 2 consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mgday
Stratum 1 consisted of patients not receiving chronic Octreotide Depot therapy will receive everolimus monotherapy at 10 mgday
Stratum 2 consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mgday
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