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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: CP-675,206 and gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556023

A3671016

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

37 participants in 1 patient group

CP-675,206 and gemcitabine

Experimental group

Treatment:

Drug: CP-675,206 and gemcitabine