Trial Information
A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose Limiting Toxicities: assessed through adverse event data collected weekly
Outcome Time Frame:
8 week intervals
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
A3671016
NCT ID:
NCT00556023
Start Date:
June 2008
Completion Date:
August 2011
Related Keywords:
- Pancreatic Cancer
- interventional
- dose-finding
- Pancreatic Neoplasms