Ignite Creation Date:
2024-05-05 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00580320
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2007-12-18
Brief Title:
Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma
Status:
COMPLETED
Status Verified Date:
2016-08
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:
Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose
Detailed Description:
The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly
Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rates duration of response time to progression and time on treatment a measure of both antitumor activity and treatment tolerance
Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rates duration of response time to progression and time on treatment a measure of both antitumor activity and treatment tolerance
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