A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas - Full Text View

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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Pancrelipase Gemcitabine Gemcitabine hydrochloride Ultrase Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

safety, tolerability, maximum tolerated dose and recommended phase 2 dose of CP-870,893 in patients with advanced pancreas cancer (phase 1) [ Time Frame: first chemotherapy cycle (28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

monitor changes in expression of B-lymphocyte activation markers (phase 1 expansion cohort) [ Time Frame: days 1-5 of 1st chemotherapy cycle ] [ Designated as safety issue: No ]
monitor changes in measured concentrations of serum cytokines following administration of CP-870,893 (phase 1) [ Time Frame: days 1 and 3 of chemotherapy cycle ] [ Designated as safety issue: Yes ]
exploration of relationship between exposure to CP-870,893 and clinical response [ Time Frame: end of study ] [ Designated as safety issue: No ]
tumor response (RECIST radiographic and PET-CT) [ Time Frame: following every even-numbered cycle and 4-6 wk following initial response ] [ Designated as safety issue: No ]
characterize single-dose pharmacokinetics of CP-870,893 in this patient population (phase 1) [ Time Frame: days 3 and 4 of chemotherapy cycle ] [ Designated as safety issue: No ]
assessment of progression-free survival and time to progression [ Time Frame: monthly until death or 7.5 mo. following treatment of last patient ] [ Designated as safety issue: No ]
assessment of overall survival [ Time Frame: monthly until death or 7.5 mo. following treatment of last patient ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	June 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single arm	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

Criteria

Inclusion Criteria:

1st-line surgically incurable cancer of the pancreas
ECOG(Eastern Cooperative Oncology Group) performance status 0-1

Exclusion Criteria:

Previous systemic therapy for pancreas cancer
History of cancer-associated blood clots
History of autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711191

Locations

United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Pfizer

University of Pennsylvania

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beatty GL, Chiorean EG, Fishman MP, Saboury B, Teitelbaum UR, Sun W, Huhn RD, Song W, Li D, Sharp LL, Torigian DA, O'Dwyer PJ, Vonderheide RH. CD40 agonists alter tumor stroma and show efficacy against pancreatic carcinoma in mice and humans. Science. 2011 Mar 25;331(6024):1612-6.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00711191 History of Changes
Other Study ID Numbers:	A5021005
Study First Received:	June 26, 2008
Last Updated:	March 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

pancreas cancer; cancer of the pancreas; gemcitabine; chemotherapy; monoclonal antibody; immunotherapy; CD40

Additional relevant MeSH terms:

Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Gemcitabine
Pancrelipase
Immunologic Factors

Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012