Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066196
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2003-08-05
Brief Title:
Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase II Randomized Open-Label Study Evaluating The Antitumor Activity Of MEDI-522 A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin Dacarbazine In Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2008-01
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:
The primary objectives of this study are
To explore the antitumor activity of MEDI-522 DTIC in patients with metastatic melanoma
To determine the safety of MEDI-522 DTIC in this patient population
To explore the antitumor activity of MEDI-522 DTIC in patients with metastatic melanoma
To determine the safety of MEDI-522 DTIC in this patient population
Detailed Description:
This is a Phase II randomized open-label two-arm multicenter study of MEDI 522 DTIC in previously untreated other than adjuvant immunotherapy patients with Stage IV metastatic melanoma AJCC staging
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