Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
|ClinicalTrials.gov Identifier: NCT00625768|
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : August 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma Metastatic Malignant Melanoma||Drug: AS1409||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
- Tumor assessment [ Time Frame: 6 weeks, response confirmed at 4 weeks ]
- 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 ]
- Adverse event monitoring [ Time Frame: Various timepoints cycles 1-6, pre- and post-dose; then 1,4 and 12 weeks post last dose ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625768
|Auckland Medical School|
|Auckland, New Zealand|
|Hamilton, New Zealand|
|London, United Kingdom, SE1 9RT|
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||James Spicer, MD||Kings College School of Medicine|