Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

Phase 1 Completed 68 enrolled AstraZeneca

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.

Timeline

Start: 2007-08
Primary completion: 2011-10
Completion: 2012-07

Publications

Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	600 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Olaparib	Small molecule	50 mg	Oral
Subject	Olaparib	Small molecule	100 mg	Oral
Subject	Olaparib	Small molecule	200 mg	Oral

Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

Summary

Timeline

Publications

Drugs

Indications