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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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.
Research Site
Edmonton, Alberta, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Candiolo (TO), Italy
Research Site
Roma, Italy
Dose Limiting Toxicities: assessed through adverse event data collected weekly
Time frame: 8 week intervals
HAHA Response to CP-675,206:
Time frame: 12 months
Lymphocyte Subset Analysis:
Time frame: 12 months
Cytokine Analysis:
Time frame: 12 months
Pharmacogenomic Analysis:
Time frame: 1 month
Overall Survival:
Time frame: 12 months
Pharmacokinetics of CP-675,206 and Gemcitabine:
Time frame: 2 months
Best Overall Response:
Time frame: 3 months
Duration of Tumor Response:
Time frame: 3 months
Progression-Free Survival:
Time frame: 5 months
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