OPERa
Research type
Research Study
Full title
A Randomised, double-blind, placebo controlled, multi-centre phase II study to assess the Efficacy and safety of 2nd line Olaparib in combination with Paclitaxel, in Western patients with advanced gastric and gastro-oesophageal junction cancer
IRAS ID
179415
Contact name
Naureen Starling
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2015-001605-14
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
The OPERa study will assess if adding olaparib to standard chemotherapy treatment improves outcomes for patients with advanced cancers of the stomach or cancer of the part of the oesophagus where it joins the stomach, the gastro-oesophageal junction (GOJ).
Paclitaxel is a standard second line treatment option for patients with advanced cancer of the stomach or GOJ. In this study all patients will receive paclitaxel treatment. In addition half of the patients will be given olaparib and half will be given a placebo tablet.
Olaparib is a type of drug called a PARP inhibitor. PARP is an enzyme, which helps damaged cells repair themselves. PARP inhibitors work by preventing cancer cells from repairing themselves when they are damaged leading to the death of the cancer cells.
A similar study was previously carried out in Asia. This study found that on average patients who received olaparib as well as paclitaxel lived for longer than patients who received placebo and paclitaxel. This study will assess if olaparib treatment improves outcomes in Western patients as it did in the Asian patients. It will also assess the side effects patients experience and how treatment affects their quality of life.
Ataxia Telangiectasia Mutated (ATM) is the name of a protein that can be looked for in cancer cells. In the Asian study, patients whose cancer cells had low levels of ATM protein had better outcomes on average with olaparib treatment than the patients with normal levels of ATM protein. The study is designed so that half the patients have low levels of ATM protein and half have normal levels. The study will then also assess if Western patients whose cancer cells have low levels of ATM protein have better outcomes with olaparib treatment than patients whose cancer cells have normal levels of ATM protein.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/1086
Date of REC Opinion
7 Jul 2015
REC opinion
Favourable Opinion