Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01058655
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2009-10-29
Brief Title:
RAD001 and AV-951 in Patients With Refractory Metastatic Colorectal Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase III Study of RAD001 and AV-951 in Patients With Refractory Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Research has shown that anti-angiogenic agents can be effective therapies to treat cancer Anti-angiogenic agents target the blood vessels required for tumors to grow Vascular endothelial growth factor VEGF is one of the cell pathways used for this blood vessel growth When the investigators interfere with the VEGF pathway the investigators inhibit this blood vessel growth which is required by tumors One of the study drugs being used tivozanib AV-951 selectively interferes with the VEGF pathway The second study drug being used everolimus RAD001 interferes with the mTOR pathway The mTOR pathway is another pathway involved in blood vessel and tumor cell growth By combining these two drugs the investigators hope to slow or reverse tumor cell growth in patients whose tumors have become resistant to other therapies for their disease
Detailed Description:
Primary Objective
Phase I
To determine the safety tolerability and maximally tolerated dose MTD of everolimus and tivozanib administered in combination to patients with advanced gastrointestinal tumors
Phase II
At the MTD to assess progression-free survival associated with everolimus and tivozanib in patients with refractory metastatic colorectal cancer
Secondary Objectives
Phase II
To assess tumor response rate
To assess overall survival
Phase I
To determine the safety tolerability and maximally tolerated dose MTD of everolimus and tivozanib administered in combination to patients with advanced gastrointestinal tumors
Phase II
At the MTD to assess progression-free survival associated with everolimus and tivozanib in patients with refractory metastatic colorectal cancer
Secondary Objectives
Phase II
To assess tumor response rate
To assess overall survival
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