Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510354
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2007-07-31
Brief Title:
Treatment of Patients With Everolimus and Imatinib Mesylate Who Have Progressive Gastro Intestinal Stromal Tumors GIST and Are Resistant to Imatinib Mesylate
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Multicenter Single-arm Two Stage Phase II Trial of RAD001 Everolimus With Imatinib in Imatinib-resistant Patients With Progressive GIST
Status:
COMPLETED
Status Verified Date:
2016-11
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:
Radix
Brief Summary:
The purpose of this multicenter single-arm Simon two-stage phase II trial is to determine the efficacy and safety of everolimus in combination with Imatinib mesylate in patients with previously treated histologically proven GIST whose disease has recurred or progressed while receiving 400 mgday of Imatinib mesylate at any time during at least a 2 months treatment period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2005-004837-16 | None | None | None |