A Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00902291|
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : September 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Pancreatic Ductal Pancreatic Cancer Pancreatic Disease||Biological: AGS-1C4D4 Biological: Gemcitabine||Phase 2|
A disease assessment will be performed at study week 8 (± 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-1C4D4 and/or gemcitabine.
Post-Treatment: Subjects terminating from protocol therapy for reasons unrelated to documented disease progression will be followed by telephone contact every 2 months until they begin a new anticancer therapy, their disease progresses, they die, become lost to follow-up or withdrawal consent for further follow-up, whichever of these events occurs first.
Overall survival: All subjects will be followed by telephone contact every 2 months until death, loss to follow-up, or withdrawal of consent, whichever of these events occurs first.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
|Active Comparator: 1. Gemcitabine monotherapy||
|Experimental: 2. Gemcitabine plus AGS-1C4D4||
- Survival rate at 6 months [ Time Frame: 6 months ]
- Overall Survival (OS) [ Time Frame: Throughout treatment period and post-treatment every 2 months until death, or subject discontinues the study ]
- Progression free survival (PFS) [ Time Frame: Throughout treatment period or post-treatment every 2 months until disease progression or death, respectively, or subject discontinues the study ]
- Change in level of serum tumor marker CA 19-9 [ Time Frame: Week 1, Week 4, Week 7 and every 3 weeks during the extended treatment period ]
- Incidence of anti-AGS-1C4D4 antibody formation [ Time Frame: Week 1, Week 7 and every 8 weeks during the extended treatment period ]
- Objective Response Rate (Partial Response or better per RECIST criteria version 1.1 [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ]
- Disease Control (Stable Disease or better per RECIST criteria) [ Time Frame: Week 8, and every 8 weeks during the extended treatment period ]
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): NCT00902291
|Study Director:||Chief Medical Officer||Agensys, Inc.|