Ignite Creation Date:
2024-05-06 @ 12:04 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01482156
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2011-09-26
Brief Title:
Dose Finding Study of RAD001 Everolimus Afinitor in Combination With BEZ235 in Patients With Advanced Solid Tumors
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Multi-center Phase I Dose-finding Study of RAD001 Everolimus Afinitor in Combination With BEZ235 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-11
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:
Study has two parts
1 Dose-finding to determine the maximum tolerated dose MTD and to evaluate the safety and tolerability of RAD001 everolimus Afinitor in combination with BEZ235 in patients with advanced solid tumors
2 Dose-expansion to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ERHER2- metastatic breast cancer and metastatic renal cell cancer
1 Dose-finding to determine the maximum tolerated dose MTD and to evaluate the safety and tolerability of RAD001 everolimus Afinitor in combination with BEZ235 in patients with advanced solid tumors
2 Dose-expansion to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ERHER2- metastatic breast cancer and metastatic renal cell cancer
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 |
|---|---|---|---|
| 2011-001425-24 | EUDRACT_NUMBER | None | None |