Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
Launched by DAIICHI SANKYO · Aug 24, 2007
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
Primary Objective:
- 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 ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
- Exclusion Criteria:
- • Anticipation of need for major surgery or radiation therapy during the study
- • 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
About Daiichi Sankyo
Daiichi Sankyo is a global healthcare company headquartered in Tokyo, Japan, dedicated to the research, development, and commercialization of innovative pharmaceuticals and vaccines. With a strong focus on oncology, cardiovascular diseases, and rare disorders, Daiichi Sankyo leverages advanced technologies and a robust pipeline to address unmet medical needs worldwide. Committed to fostering collaboration and scientific excellence, the company engages in clinical trials that aim to bring transformative therapies to patients while adhering to the highest standards of safety and efficacy. Through its comprehensive approach to drug development, Daiichi Sankyo strives to improve patient outcomes and enhance the quality of life for individuals around the globe.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Richmond, Virginia, United States
Nashville, Tennessee, United States
Minneapolis, Minnesota, United States
Birmingham, Alabama, United States
Washington, District Of Columbia, United States
Cincinnati, Ohio, United States
Decatur, Georgia, United States
Chattanooga, Tennessee, United States
Tucker, Georgia, United States
Fort Myers, Florida, United States
Temple, Texas, United States
Patients applied
Trial Officials
Global Clinical Leader
Study Director
Daiichi Sankyo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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