A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556023
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and 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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: CP-675,206 and gemcitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
Study Start Date : June 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CP-675,206 and gemcitabine 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.

Primary Outcome Measures :
  1. Dose Limiting Toxicities: assessed through adverse event data collected weekly [ Time Frame: 8 week intervals ]

Secondary Outcome Measures :
  1. HAHA Response to CP-675,206: [ Time Frame: 12 months ]
  2. Lymphocyte Subset Analysis: [ Time Frame: 12 months ]
  3. Cytokine Analysis: [ Time Frame: 12 months ]
  4. Pharmacogenomic Analysis: [ Time Frame: 1 month ]
  5. Overall Survival: [ Time Frame: 12 months ]
  6. Pharmacokinetics of CP-675,206 and Gemcitabine: [ Time Frame: 2 months ]
  7. Best Overall Response: [ Time Frame: 3 months ]
  8. Duration of Tumor Response: [ Time Frame: 3 months ]
  9. Progression-Free Survival: [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556023

Canada, Alberta
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3T 1E2
Research Site
Candiolo (TO), Italy, 10060
Research Site
Roma, Italy, 00168
Sponsors and Collaborators

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00556023     History of Changes
Other Study ID Numbers: A3671016
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies, Monoclonal
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs