Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
NCT ID: NCT00521404
Last Updated: 2021-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2007-08-15
2010-08-20
Brief Summary
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Detailed Description
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\- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
* To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
* To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
* To study potential biomarkers of CS-1008 activity
* To assess possible human anti-human antibody formation after exposure to CS-1008
* To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CS-1008 + gemcitabine
CS-1008 + gemcitabine
CS-1008 (humanized anti-DR5 antibody)
CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
gemcitabine
Gemcitabine - 1000mg/meter sq
Interventions
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CS-1008 (humanized anti-DR5 antibody)
CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
gemcitabine
Gemcitabine - 1000mg/meter sq
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
* Clinically significant active infection or history of HIV
* Partial or complete bowel obstruction
* Poorly controlled psychiatric illness
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Birmingham, Alabama, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Atlanta, Georgia, United States
Georgia Cancer Specialists
Tucker, Georgia, United States
Decatur, Illinois, United States
Minneapolis, Minnesota, United States
Cincinnati, Ohio, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Temple, Texas, United States
Richmond, Virginia, United States
Countries
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Other Identifiers
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CS1008-A-U201
Identifier Type: -
Identifier Source: org_study_id
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