Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

Summary

This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

Timeline

Start

2013-09-03

Primary completion

2016-04-04

Completion

2023-03-27

Outcome

Missed primary endpoint

paper The GOLD study did not meet its primary objective of showing a significant improvement in overall survival with olaparib in the overall or ATM-negative population PMID 29103871 ↗

release “did not meet the primary endpoint of overall survival (OS) in the Phase III GOLD trial in advanced gastric cancer patients” astrazeneca.com ↗

Publications

• Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, Qin S, Xu N, Im SA, Locker G, Rowe P, Shi X, Hodgson D, Liu YZ, Boku N. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1637-1651. doi: 10.1016/S1470-2045(17)30682-4. Epub 2017 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olaparib	Small molecule	300 mg	Oral
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications