Pancreatic Cancer
Conditions
Keywords
interventional, dose-finding
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.
Interventions
DRUGCP-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.
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicities: assessed through adverse event data collected weekly | 8 week intervals |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte Subset Analysis: | 12 months |
| Cytokine Analysis: | 12 months |
| Pharmacogenomic Analysis: | 1 month |
| Overall Survival: | 12 months |
| HAHA Response to CP-675,206: | 12 months |
| Best Overall Response: | 3 months |
| Duration of Tumor Response: | 3 months |
| Progression-Free Survival: | 5 months |
| Pharmacokinetics of CP-675,206 and Gemcitabine: | 2 months |
Countries
Canada, Italy
Outcome results
None listed