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Research & Clinical Trials > Study Search Tool > Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

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Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

This study is open to:

Patients with advanced (metastatic) pancreatic cancer who:

  • have a documented mutation in BRCA1 or BRCA2. Note: patients can receive genetic testing prior to participating in the study. 
  • have recently completed initial platinum-based chemotherapy for metastatic disease (at least 16weeks of treatment) and have no evidence of disease progression OR...
    …are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer and have no evidence of progression.
  • can be at a point in chemotherapy where both they and their doctor believe having a pause or break in chemotherapy treatment is appropriate.
This study is not open to:

Patients are excluded if they:

  • have progression of tumor between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomization for the clinical trial. 
  • have been previously treated with any PARP inhibitor, is ineligible. 
  • do not have a BRCA mutation as confirmed by genetic test.
  • have received any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomization for the study.
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)

POLO - Olaparib in BRCA-Associated Pancreatic Cancer

Clinicaltrials.gov identifier:
NCT02184195

Treatment:
Pancreatic

Study Contact Information

POLO is open at over 100 locations globally. In the U.S. you can call the AstraZeneca Cancer Study Locator toll free at: 1-877-400-4656 or by email to get more information and find a study doctor near you.

POLO is enrolling in the following states:

  • Arizona
  • California
  • Colorado
  • Connecticut
  • Florida
  • Illinois
  • Maryland
  • Massachusetts
  • Missouri
  • New Jersey
  • New York
  • Pennsylvania
  • Texas
  • Washington

POLO is also enrolling in the following countries

  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Korea
  • Netherlands
  • Spain
  • United Kingdom

ABOUT the Study

POLO is a clinical trial enrolling people with metastatic (advanced) pancreatic cancer patients with BRCA mutations to determine whether adding the PARP inhibitor, olaparib after first line chemotherapy improves survival. 

Patients who enroll in the study will be randomly assigned to one of two groups once they have completed chemotherapy. One group will receive olaparib, a type of medication known as a PARP inhibitor, a category of medication that has been studied in people BRCA mutations and certain types of cancer. The other group will receive a placebo, also known as a sugar pill.

Visit the study website for more information. 

Type of Study:

Randomized, Double-blinded, Placebo-controlled, Maintenance Study

  • The study has two arms. This means that patients in the study are placed in one of two different groups. One group will receive the PARP inhibitor Olaparib and the other group will receive a placebo
  • This is a randomized study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. This randomizing is 3:2. This means that patients will have a slightly greater chance of being placed in the treatment group than the placebo group. 
  • The study is double-blinded. This means that participants will be randomly selected to one of two groups. Neither the participants nor their doctors will know whether they are receiving olaparib or the placebo while participating in the study. 
  • The study is placebo-controlled. Placebos are harmless sugar pills. Placebos are only used in research in situations where there is no standard treatment. Patients begin the study only after they complete standard treatment and only if they respond to treatment.
  • The study is a maintenance study. Maintenance therapy is given after initial standard treatment has been completed to try to keep the cancer from returning. This is a time when pancreatic patients do not usually receive treatment. Currently experts do not know if giving olaparib as maintenance therapy to patients with pancreatic cancer after they have finished chemotherapy improves their survival or outcome. Some emerging research has suggested that maintenance therapy with a PARP inhibitor after chemotherapy can help patients with ovarian cancer have a longer time period before their cancer comes back. 

What the Study Entails

  • Patients who have not already had genetic testing will undergo genetic testing to see if they carry a BRCA1 or BRCA2 mutation. Only patients with a BRCA mutation will be eligible to participate. This test will be free of charge for patients.
  • Patients must have reached a point in chemotherapy where both they and their doctor believe having a pause or break in chemotherapy treatment is appropriate. 
  • Participants will be randomized 3:2 to receive either the oral PARP inhibitor olaparib (300 mg) twice daily or a placebo twice daily. 3:2 randomization means that for every 3 patients who are chosen to receive the PARP inhibitor, 2 will be chosen to receive the placebo. Patients have better than a 50/50 chance of receiving the study agent. 
  • Patients will need to attend regular clinic visits and undergo associated laboratory tests to assess their health status and response to treatment. 
  • Patients whose cancer progresses will be taken off the study and will need to consult with their oncologist about other treatment options. 

The study schema (diagram of what the study entails) is available here

Visit the study website for more information. 

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