Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01048723
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2010-01-13
Brief Title:
Study of RAD001 in Soft Tissue Extremity andor Retroperitoneal Sarcomas
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Single-arm Open Label Phase II Study of RAD001 in Soft Tissue Extremity andor Retroperitoneal Sarcomas
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Novartis terminated funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma The patients physical state their symptoms changes in the size of the tumor and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective in patients with this condition The study drug RAD001 is made by Novartis Pharmaceuticals Corporation
Detailed Description:
A single-arm open label proof of principle phase II study exploring the efficacy of RAD001 in resectable soft tissue sarcomas either in the extremities trunk or retroperitoneum Patients with resectable sarcomas as detailed below were to have a core biopsy for molecular markers prior to therapy with RAD001 10mg PO daily x 2 weeks Within 7-14 days of the end of therapy with RAD001 the patients were to be brought to surgery for definitive resection or should they be candidates for neoadjuvant radiation would have 6 16 gauge core biopsies taken percutaneously or using image guidance Pharmacodynamic markers as detailed in the objectives were to be assessed in the laboratory
Patients were to be numbered sequentially from 1 to 40 or more if there were patients that dropped out due to drug toxicity with the goal of achieving 40 patients in accrual for evaluation of the pre- and post-treatment tumor samples for Pharmacodynamic assays
Patients were to be numbered sequentially from 1 to 40 or more if there were patients that dropped out due to drug toxicity with the goal of achieving 40 patients in accrual for evaluation of the pre- and post-treatment tumor samples for Pharmacodynamic assays
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 |
|---|---|---|---|
| 108182 | OTHER | USF IRB | None |
| CRAD001CUS107T | OTHER | None | None |