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

Phase 1 Completed 37 enrolled AstraZeneca

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2008-06
Primary completion: 2011-08
Completion: 2011-08

Publications

Aglietta M, Barone C, Sawyer MB, Moore MJ, Miller WH Jr, Bagala C, Colombi F, Cagnazzo C, Gioeni L, Wang E, Huang B, Fly KD, Leone F. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer. Ann Oncol. 2014 Sep;25(9):1750-1755. doi: 10.1093/annonc/mdu205. Epub 2014 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tremelimumab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Tremelimumab	Monoclonal antibody	15 mg/kg	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications