A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Cancer
Intervention: monoclonal antibody (Biological); chemotherapy (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com
Summary
This study aims to seek evidence that activation of certain cells of the immune system will
enhance chemotherapy effect to prolong survival of patients with advanced cancer of the
pancreas
Clinical Details
Official title: A Phase 1 Dose Escalation/Phase 2, Single-Armed, Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: safety, tolerability, maximum tolerated dose and recommended phase 2 dose of CP-870,893 in patients with advanced pancreas cancer (phase 1)overall survival of patients with advanced pancreas cancer treated with CP-870,893 in combination with gemcitabine (phase 2)
Secondary outcome: monitor changes in expression of B-lymphocyte activation markers phase 1 expansion cohort)monitor changes in measured concentrations of serum cytokines following administration of CP-870,893 (phase 1) exploration of relationship between exposure to CP-870,893 and clinical response tumor response (RECIST) characterize single-dose pharmacokinetics of CP-870,893 in this patient population (phase 1) assessment of progression-free survival and time to progression (phase 2)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1st-line surgically incurable cancer of the pancreas ECOG performance status 0-1
Exclusion Criteria:
Previous systemic therapy for pancreas cancer
Locations and Contacts
Pfizer Oncology Clinical Trial Information Service, Phone: 1-877-369-9753, Email: PfizerCancerTrials@emergingmed.com
Pfizer Investigational Site, Indianapolis, Indiana 46202, United States; Recruiting
Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: June 2008
Ending date: May 2011
Last updated: October 27, 2008
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