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| Sponsor: | Pfizer |
|---|---|
| Collaborator: |
University of Pennsylvania |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00711191 |
Purpose
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Neoplasm |
Biological: monoclonal antibody Drug: chemotherapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 1 Dose Escalation Open Label Study Of CP-870,893 In Combination With Gemcitabine In Patients With Chemotherapy-Naïve Surgically Incurable Pancreatic Cancer |
| Estimated Enrollment: | 21 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| single arm: Experimental |
Biological: monoclonal antibody
CP-870,893 IV on day 3 of 4-wk cycles
Drug: chemotherapy
gemcitabine 1000 mg/m2 IV qWk x3 of 4-wk cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | |
| Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
| United States, Indiana | |
| Pfizer Investigational Site | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A5021005 |
| Study First Received: | June 26, 2008 |
| Last Updated: | February 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00711191 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
pancreas cancer, cancer of the pancreas, gemcitabine, |
chemotherapy, monoclonal antibody, immunotherapy; CD40 |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Antibodies, Monoclonal Neoplasms by Site Therapeutic Uses Gemcitabine Immunoglobulins |
Endocrine Gland Neoplasms Digestive System Neoplasms Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Antibodies Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |