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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 currently recruiting participants.
Verified November 2017 by AstraZeneca
Sponsor:
ClinicalTrials.gov Identifier:
NCT02184195
First Posted: July 9, 2014
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition Intervention Phase
Germline BRCA1/2 Mutations and Metastatic Adenocarcinoma of the Pancreas Drug: Olaparib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression free survival (PFS) by central review of modified RECIST 1.1 [ Time Frame: Up to 4 years ]
    Efficacy by assessment of PFS (time from randomisation to objective disease progression according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) or death) of olaparib maintenance monotherapy compared to placebo, using blinded independent central review (BICR) of radiological scans.


Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to 4 years ]
    Efficacy by assessment of OS (time from randomisation to death by any cause) of olaparib maintenance monotherapy compared to placebo

  • Time from randomisation to second progression or death (PFS2) [ Time Frame: Up to 4 years ]
    Efficacy by assessment of PFS2 (time from randomisation to second progression, defined as objective radiological or symptomatic progression, or death) of olaparib maintenance monotherapy compared to placebo.

  • Time from randomisation to first subsequent therapy or death (TFST) [ Time Frame: Up to 4 years ]
    Efficacy by assessment of TFST (time from randomisation to the earlier of first subsequent therapy following study treatment discontinuation, or death) of olaparib maintenance monotherapy compared to placebo.

  • Time from randomisation to second subsequent therapy or death (TSST) [ Time Frame: Up to 4 years ]
    Efficacy by assessment of TSST (time from randomisation to the earlier of second subsequent therapy following study treatment discontinuation, or death) of olaparib maintenance monotherapy compared to placebo.

  • Time from randomisation to study treatment discontinuation or death (TDT) [ Time Frame: Up to 4 years ]
    Efficacy by assessment of TDT (time from randomisation to the earlier of study treatment discontinuation or death) of olaparib maintenance monotherapy compared to placebo. compared to placebo.

  • Objective response rate by BICR using modified RECIST 1.1 [ Time Frame: Up to 4 years. ]
    Efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo

  • Disease control rate by BICR using modified RECIST 1.1 [ Time Frame: Up to 4 years ]
    Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.

  • Adjusted mean change from baseline in global quality of life (QoL) score from the EORTC-QLQ-C30 questionnaire [ Time Frame: Up to 4 years ]
    Assessment of the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale

  • Safety and tolerability of olaparib [ Time Frame: Up to 4 years ]
    Assessment of adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry and haematology.

  • Improvement rate of global quality of life (QoL) [ Time Frame: Up to 4 years ]
    Assessment of the effect of olaparib on improvement rate of global health status/QoL and pancreatic pain as measured by the EORTC-QLQ-C30 global QoL scale and the PAN-26 pancreatic pain scale.


Estimated Enrollment: 145
Actual Study Start Date: December 16, 2014
Estimated Study Completion Date: July 31, 2019
Estimated Primary Completion Date: May 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaparib
Olaparib tablets po. 300 mg twice daily
Drug: Olaparib
Tablet -100mg
Drug: Olaparib
Tablet-150mg
Placebo Comparator: Placebo
Placebo tablets twice daily
Drug: Placebo
Match Olaparib 100mg placebo
Drug: Placebo
Match Olaparib 150mg placebo

Detailed Description:

Approximately 145 patients will be randomised using an Interactive Voice Response System /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the treatments as specified below:

  • Olaparib tablets p.o. 300 mg twice daily
  • Matching placebo tablets p.o. twice daily Eligible patients will be those patients with pancreas cancer previously treated for metastatic disease who have not progressed following completion of at least 16 weeks (can be more) of first line platinum-based chemotherapy. All patients must have a known deleterious or suspected deleterious germline BRCA mutation to be randomised; this may have been determined prior to enrolment into the study or may be assessed as part of the enrolment procedure for the study (via centrally provided MyriadIntegrated BRAC.

Patients will be randomised within 6 weeks after their last dose of chemotherapy (last dose is the day of the last infusion) and treatment started as soon as possible but no less than 4 and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol treatment, all previous chemotherapy treatment should be discontinued.

Following randomisation, patients will attend clinic visits weekly for the first 4 weeks of treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks whilst on study treatment. Patients should continue to receive study treatment until objective radiological disease progression as per RECIST as assessed by the investigator and as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria.

Once a patient has progressed the patient will be followed for second progression (PFS2) every 8 weeks and then survival until the final analysis.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial chemotherapy for metastatic disease and without evidence of disease progression on treatment
  • Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in this study.
  • Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
  • Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16 weeks of continuous platinum treatment and have no evidence of progression based on investigator's opinion.
  • Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and initiation of the platinum-based chemotherapy for metastatic pancreas cancer.

Major Exclusion Criteria:

  • gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg, "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favour polymorphism" or "benign polymorphism" etc.)
  • Progression of tumour between start of first line platinum based chemotherapy for metastatic pancreas cancer and randomisation.
  • Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle

    1 Day 1 is not permitted.

  • Exposure to an investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
  • Any previous treatment with a PARP inhibitor, including Olaparib
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184195


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 astrazeneca@emergingmed.com

  Hide Study Locations
Locations
United States, Arizona
Research Site Recruiting
Gilbert, Arizona, United States, 85234
United States, California
Research Site Withdrawn
Downey, California, United States, 90241
Research Site Withdrawn
La Jolla, California, United States, 92093
Research Site Withdrawn
Los Angeles, California, United States, 90030
Research Site Withdrawn
Los Angeles, California, United States, 90048
Research Site Recruiting
Orange, California, United States, 92868
Research Site Withdrawn
Santa Monica, California, United States, 90404
Research Site Recruiting
Stanford, California, United States, 94305-5720
United States, Colorado
Research Site Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Research Site Recruiting
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Research Site Withdrawn
Washington, District of Columbia, United States, 20007
United States, Florida
Research Site Recruiting
Boca Raton, Florida, United States, 33486
Research Site Withdrawn
Miami, Florida, United States, 33136
Research Site Recruiting
Miami, Florida, United States, 33136
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637
Research Site Withdrawn
Evanston, Illinois, United States, 60201
United States, Maryland
Research Site Recruiting
Baltimore, Maryland, United States, 21231
Research Site Withdrawn
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114-2696
Research Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Research Site Not yet recruiting
Basking Ridge, New Jersey, United States, 7920
United States, New York
Research Site Recruiting
Commack, New York, United States, 11725
Research Site Not yet recruiting
Harrison, New York, United States, 10604
Research Site Not yet recruiting
New York, New York, United States, 10015
Research Site Recruiting
New York, New York, United States, 10032
Research Site Recruiting
New York, New York, United States, 10065
Research Site Recruiting
Rockville Center, New York, United States, 11570-1000
Research Site Not yet recruiting
Sleepy Hollow, New York, United States
United States, Ohio
Research Site Completed
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site Withdrawn
Spartanburg, South Carolina, United States, 29303
United States, Texas
Research Site Withdrawn
Arlington, Texas, United States, 76012
Research Site Withdrawn
Dallas, Texas, United States, 75235
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Washington
Research Site Recruiting
Seattle, Washington, United States, 98104
Research Site Withdrawn
Seattle, Washington, United States, 98109
Australia
Research Site Recruiting
Campbelltown, Australia, 2560
Research Site Withdrawn
Lilydale, Australia, 3140
Research Site Recruiting
Randwick, Australia, 2031
Research Site Recruiting
St Leonards, Australia, 2065
Research Site Withdrawn
Woolloongabba, Australia, 4102
Belgium
Research Site Recruiting
Antwerpen, Belgium, 2020
Research Site Recruiting
Brussels (Anderlecht), Belgium, 1070
Research Site Recruiting
Edegem, Belgium, 2650
Research Site Recruiting
Leuven, Belgium, 3000
Canada, Manitoba
Research Site Withdrawn
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Research Site Completed
London, Ontario, Canada, N6A 5A5
Research Site Withdrawn
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Research Site Recruiting
Montreal, Quebec, Canada, H2W 1S6
Research Site Withdrawn
Montreal, Quebec, Canada, H2X 3J4
Research Site Recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Canada
Research Site Recruiting
Toronto, Canada, M5G 2M9
France
Research Site Recruiting
Amiens, France, 80054
Research Site Recruiting
Besançon, France, 25030
Research Site Recruiting
Bordeaux, France, 33075
Research Site Not yet recruiting
Brest Cedex, France, 29609
Research Site Recruiting
Clichy Cedex, France, 92118
Research Site Recruiting
La Roche sur Yon, France, 85925
Research Site Recruiting
Lille, France, 59020
Research Site Recruiting
Lyon Cedex 03, France, 69437
Research Site Not yet recruiting
Lyon, France, 69008
Research Site Withdrawn
Montpellier, France, 34298
Research Site Recruiting
Nice, France, 06189
Research Site Recruiting
Paris CEDEX 14, France, 75674
Research Site Recruiting
Paris, France, 75014
Research Site Recruiting
Poitiers, France, 86021
Research Site Withdrawn
Rennes, France, 35042
Research Site Not yet recruiting
STRASBOURG Cedex, France, 67065
Research Site Not yet recruiting
Toulouse, France, 31059
Research Site Recruiting
Villejuif, France, 94800
Germany
Research Site Recruiting
Berlin, Germany, 10967
Research Site Recruiting
Berlin, Germany, 13353
Research Site Recruiting
Bochum, Germany, 44791
Research Site Recruiting
Bonn, Germany, 53127
Research Site Recruiting
Dresden, Germany, 01307
Research Site Recruiting
Frankfurt am Main, Germany, 60596
Research Site Withdrawn
Freiburg im Breisgau, Germany, 79106
Research Site Recruiting
Hamburg, Germany, 20246
Research Site Recruiting
Hamburg, Germany, 22291
Research Site Recruiting
Hannover, Germany, 30625
Research Site Not yet recruiting
Leipzig, Germany, 04103
Research Site Recruiting
München, Germany, 81675
Research Site Recruiting
Schweinfurt, Germany, 97422
Research Site Recruiting
Ulm, Germany, 89081
Israel
Research Site Recruiting
Beer-Sheva, Israel, 8410101
Research Site Recruiting
Haifa, Israel, 31096
Research Site Completed
Holon, Israel, 58100
Research Site Recruiting
Nahariya, Israel, 22100
Research Site Recruiting
Petah Tikva, Israel, 49100
Research Site Recruiting
Ramat Gan, Israel, 52621
Research Site Recruiting
Rehovot, Israel, 76100
Research Site Recruiting
Tel Aviv, Israel, 64239
Research Site Recruiting
Zefir, Israel, 6093000
Italy
Research Site Withdrawn
Ancona, Italy, 60126
Research Site Not yet recruiting
Bologna, Italy, 40138
Research Site Recruiting
Milano, Italy, 20132
Research Site Recruiting
Milano, Italy, 20133
Research Site Not yet recruiting
Monserrato, Italy, 09042
Research Site Completed
Padova, Italy, 35128
Research Site Completed
Parma, Italy, 43126
Research Site Not yet recruiting
Pescara, Italy, 65100
Research Site Not yet recruiting
Pisa, Italy, 56124
Research Site Not yet recruiting
Roma, Italy, 00128
Research Site Recruiting
Roma, Italy, 00144
Research Site Recruiting
San Giovanni Rotondo, Italy, 71013
Research Site Recruiting
Verona, Italy, 37134
Korea, Republic of
Research Site Recruiting
Seongnam-si, Korea, Republic of, 13620
Research Site Recruiting
Seoul, Korea, Republic of, 135710
Research Site Recruiting
Seoul, Korea, Republic of
Netherlands
Research Site Recruiting
Amsterdam, Netherlands, 1105 AZ
Research Site Withdrawn
Maastricht, Netherlands, 6229 HX
Spain
Research Site Recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Girona, Spain, 17007
Research Site Recruiting
L'Hospitalet de Llobregat, Spain, 08907
Research Site Recruiting
Madrid, Spain, 28007
Research Site Recruiting
Madrid, Spain, 28034
Research Site Recruiting
Madrid, Spain, 28041
Research Site Recruiting
Madrid, Spain, 28050
Research Site Recruiting
Málaga, Spain, 29010
Research Site Recruiting
Pamplona, Spain, 31008
Research Site Recruiting
Sabadell, Spain, 8208
Research Site Recruiting
Santiago De Compostela(A Coru, Spain, 15706
Research Site Recruiting
Valencia, Spain, 46009
Research Site Completed
Zaragoza, Spain, 50009
United Kingdom
Research Site Recruiting
Edinburgh, United Kingdom, EH4 2XU
Research Site Recruiting
Glasgow, United Kingdom, G12 0YN
Research Site Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Research Site Recruiting
Liverpool, United Kingdom, L69 3GA
Research Site Recruiting
London, United Kingdom, SE5 9RS
Research Site Recruiting
London, United Kingdom, WC1E 6BT
Research Site Recruiting
Manchester, United Kingdom, M20 4BX
Research Site Recruiting
Northwood, United Kingdom, HA6 2RN
Research Site Recruiting
Nottingham, United Kingdom, NG5 1PB
Research Site Recruiting
Surrey, United Kingdom, SM1 2DL
Sponsors and Collaborators
AstraZeneca
Myriad Genetic Laboratories, Inc.
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02184195     History of Changes
Other Study ID Numbers: D081FC00001
2014-001589-85 ( EudraCT Number )
First Submitted: June 6, 2014
First Posted: July 9, 2014
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by AstraZeneca:
BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents