A Phase 1 Study Testing CP-675,206 + Gemcitabine in Patients With Previously Treated, Advanced Pancreatic Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00556023

Purpose

To Determine the Safety and Tolerability of Different Doses of CP-675,206 in Combination with Gemcitabine; To Determine the Maximum Dose of CP-675,206 That is Well Tolerated When Given in Combination With Gemcitabine to Patients With Advanced Pancreatic Cancer

Condition	Intervention	Phase
Pancreatic Cancer	Drug: CP-675,206 and gemcitabine	Phase I

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Dose Limiting Toxicities: assessed through adverse event data collected weekly [ Time Frame: 8 week intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HAHA Response to CP-675,206: [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Lymphocyte Subset Analysis: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cytokine Analysis: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pharmacogenomic Analysis: [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Overall Survival: [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Pharmacokinetics of CP-675,206 and Gemcitabine: [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Best Overall Response: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Duration of Tumor Response: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Progression-Free Survival: [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-675,206 and gemcitabine: Experimental	Drug: CP-675,206 and gemcitabine Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.

Arms

Assigned Interventions

CP-675,206 and gemcitabine: Experimental

Drug: CP-675,206 and gemcitabine

Escalating doses of CP-675,206 will be administered by IV infusion on day 1 of each 84-day treatment cycles (doses of 6, 10 and 15 mg/kg are planned). Gemcitabine will be administered by IV infusion, at a fixed dose of 1000 mg/m2 on days 1 (prior to CP-675,206) and again on days 8, 15, 29, 36, 43, 57, 64, and 71. Repeated cycles of gemcitabine and CP-675,206 will be administered until patients develop progressive disease or unacceptable toxicity, or for a maximum of 4 cycles, whichever occurs first.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with metastatic pancreatic cancer
Patient must have adequate bone marrow, liver and kidney function
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Chemotherapy naive
Inoperable pancreatic cancer

Exclusion Criteria:

Patient must not have received prior systemic therapy for pancreatic cancer
Patient must not have previously received anti-CTLA4 therapy
History of chronic inflammatory or autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556023

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

Canada, Alberta
Pfizer Investigational Site	Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Pfizer Investigational Site	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Pfizer Investigational Site	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Italy
Pfizer Investigational Site	Recruiting
Candiolo (TO), Italy, 10060
Pfizer Investigational Site	Recruiting
Roma, Italy, 00168

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3671016
Study First Received:	November 8, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00556023
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

interventional, dose-finding

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009