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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: CP-675,206 and gemcitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-675,206 and gemcitabine<br> | Drug: CP-675,206 and gemcitabine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities: assessed through adverse event data collected weekly |  | 8 week intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAHA Response to CP-675,206: |  | 12 months | 
| Lymphocyte Subset Analysis: |  | 12 months | 
| Cytokine Analysis: |  | 12 months | 
| Pharmacogenomic Analysis: |  | 1 month | 
| Overall Survival: |  | 12 months | 
| Pharmacokinetics of CP-675,206 and Gemcitabine: |  | 2 months | 
| Best Overall Response: |  | 3 months | 
| Duration of Tumor Response: |  | 3 months | 
| Progression-Free Survival: |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interventional, dose-finding