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Spots Global Cancer Trial Database for Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

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Trial Identification

Brief Title: Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer

Official Title: Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer

Study ID: NCT00521404

Study Description

Brief Summary: Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.

Detailed Description: 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 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Birmingham, Alabama, United States

, Washington, 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

Contact Details

Name: Global Clinical Leader

Affiliation: Daiichi Sankyo

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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