Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
- Drug: AS1409
Study drugOther Name: huBC1-huIL-12
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|