Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412828
Status:
COMPLETED
Last Update Posted:
2015-02-19
First Post:
2006-12-18
Brief Title:
A Phase III Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
Sponsor:
CuraGen Corporation
Organization:
Celldex Therapeutics
Study Overview
Official Title:
A Phase III Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-02
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:
This study will evaluate the safety tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy CR011-vcMMAE will be administered intravenously IV once every 3 weeks at escalating doses until the maximum tolerated dose MTD is reached Once the MTD is defined 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level Additional dosing schedules of CR011-vcMMAE will also be explored
Detailed Description:
None
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