Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
This study has been completed.
Information provided by:
First received: February 20, 2008
Last updated: August 24, 2009
Last verified: August 2009
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
Metastatic Renal Cell Carcinoma
Metastatic Malignant Melanoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Antisoma Research:
Primary Outcome Measures:
- Tumor assessment [ Time Frame: 6 weeks, response confirmed at 4 weeks ] [ Designated as safety issue: No ]
- Biomarkers (interferon-γ and IP-10 Interferon) [ Time Frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose ] [ Designated as safety issue: No ]
- Adverse event monitoring [ Time Frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Intervention Details:Detailed Description:
Other Name: huBC1-huIL-12
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00625768
|Auckland Medical School|
|Auckland, New Zealand|
|Hamilton, New Zealand|
|London, United Kingdom, SE1 9RT|
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
Sponsors and Collaborators
|Principal Investigator:||James Spicer, MD||Kings College School of Medicine|