Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT00518895
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2007-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Sponsor:
Genta Incorporated
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Status:
COMPLETED
Status Verified Date:
2009-04
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:
AGENDA
Brief Summary:
This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GM307 | None | None | View |