Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01658436
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2012-07-06
Brief Title:
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors pNET After Failure of mTOR Inhibitor Therapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Multicenter Two Stage Phase II Study Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care BSC Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors pNET After Failure of mTOR Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2016-04
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:
This is a Phase II study in 2 stages evaluating BEZ235 plus best supportive care BSC versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors pNET after failure of mTOR inhibitor therapy
Study design This was a Phase II two-stage multicenter study where Stage 1 was a single arm open label design and Stage 2 was planned to be a randomized double-blind study
However at the end of Stage 1 the futility was met and hence the Stage 2 was not initiated
Study design This was a Phase II two-stage multicenter study where Stage 1 was a single arm open label design and Stage 2 was planned to be a randomized double-blind study
However at the end of Stage 1 the futility was met and hence the Stage 2 was not initiated
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-000675-16 | EUDRACT_NUMBER | None | None |