POLO
Research type
Research Study
Full title
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
IRAS ID
158949
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
Astrazeneca AB
Eudract number
2014-001589-85
Research summary
Summary of Research
Pancreatic cancer occurs when cells in the pancreas grow out of control, forming a mass of tissue called a tumour. In well over 95% of the cases the cancer starts from exocrine pancreatic cells, which are cells producing digestive juices or forming the tubes that lead these juices to the bowels. Pancreatic ductal adenocarcinoma is the most common subtype, making up about 90% of all exocrine pancreas tumours. There are also less common variants of pancreatic cancer.
Pancreas cancer can start to grow anywhere in the pancreas. The most common location is the head of the pancreas. The tumour can cross the border of the pancreas and grow into neighbouring organs. Also, the tumour can spread via lymph vessels to lymph nodes. In advanced cases the tumour can also spread to other organs via the blood stream and form metastases in the liver, abdomen, lungs, bones, brain, etc.
The treatment options for pancreatic cancer fall into three main types. Surgery and endoscopic procedures can be used to completely remove the cancer in early stages and help to manage complications in any stages of the tumour. Radiotherapy can be used to control the tumour in combination with surgery or chemotherapy and to control tumour related pain.
Chemotherapy can be used before and after surgery to reduce the chances of the cancer coming back or without surgery to control the growth of the cancer and improve the cancer related symptoms.
Olaparib is a new drug of the class of PARP inhibitors and has shown signs of activity in different types of cancer related to BRCA mutations. The purpose of this clinical study is to see if Olaparib is effective in treating pancreatic cancer in patients with BRCA mutations and in preventing the cancer from worsening during a pause in chemotherapy. The study is placebo controlled, which means that 60% of the study participants will receive Olaparib and 40% will receive placebo (tablets with the same appearance that do not contain the active medication). This is a double blinded study meaning neither the study participant nor the study doctor will know which medication will be given. If the cancer worsens under the study treatment (Olaparib or placebo) the patient will receive further chemotherapy and/or other treatment options as needed.
Approximately 145 other patients will take part in approximately 80 hospitals worldwide.
This study is being funded by AstraZeneca.Summary of Results
The Lay Summary is not currently available. This is an old study and there is no expectation for patients to receive one as it was not included in the ICF. All results are visible on ct.gov.
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1672
Date of REC Opinion
3 Nov 2014
REC opinion
Further Information Favourable Opinion