Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT00625768
Status:
COMPLETED
Last Update Posted:
2009-08-25
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
Sponsor:
Antisoma Research
Organization:
Study Overview
Official Title:
A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2009-08
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:
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Detailed Description:
* To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose (MTD) of AS1409 in single and repeated doses.
* To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
* To determine preliminary pharmacokinetics of AS1409.
* To determine the immunogenicity of AS1409
* To explore the anti-tumour activity of AS1409.
* To determine biological responses to AS1409, including interferon-γ and IP-10 circulating concentrations.
* To determine preliminary pharmacokinetics of AS1409.
* To determine the immunogenicity of AS1409
* To explore the anti-tumour activity of AS1409.
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?: