Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284817
Status:
COMPLETED
Last Update Posted:
2008-05-29
First Post:
2006-01-31
Brief Title:
Phase I Study of MEDI522 in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
Phase I Study of MEDI522 a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin in Patients With Irinotecan-Refractory Advanced Colorectal Cancer or Other Solid Tumors Refractory to Standard Therapy
Status:
COMPLETED
Status Verified Date:
2008-05
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:
- Assess the safety and tolerance of a weekly MEDI522 regimen in patients with irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy
Detailed Description:
Assess the safety and tolerance of a weekly MEDI 522 regimen in patients with irinotecan-refractory advanced CRC
Determine a Phase II recommended dose based on acceptable dose-limiting toxicity Other considerations such as pharmacokinetic parameters may also be factored into the determination of a Phase II dose
The secondary objectives of the study are to
Assess any antitumor activity of MEDI-522 in this patient population
Determine a Phase II recommended dose based on acceptable dose-limiting toxicity Other considerations such as pharmacokinetic parameters may also be factored into the determination of a Phase II dose
The secondary objectives of the study are to
Assess any antitumor activity of MEDI-522 in this patient population
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