QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
|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: NCT00630552|
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas Metastatic Pancreatic Cancer Pancreatic Cancer||Other: Placebo Drug: AMG 479 Drug: AMG 655||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||April 2012|
|Placebo Comparator: Placebo + Gemcitabine||
Inactive dummy of AMG 655.
|Experimental: AMG 655 + Gemcitabine||
Drug: AMG 655
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
|Experimental: AMG 479 + Gemcitabine||
Drug: AMG 479
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
- Survival [ Time Frame: 6 months ]
- Safety [ Time Frame: Length of the study ]
- Safety and Efficacy Endpoints [ Time Frame: Length of the study ]
- Overall Survival [ Time Frame: Length of the study ]
- Time to Response [ Time Frame: Length of the study ]
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): NCT00630552
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