Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
POLO
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
2 other identifiers
interventional
154
12 countries
103
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2014
Longer than P75 for phase_3
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
December 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedResults Posted
Study results publicly available
January 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2023
CompletedSeptember 13, 2023
June 1, 2023
4.1 years
June 6, 2014
January 14, 2020
August 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
Up to 4 years
Secondary Outcomes (9)
Overall Survival (OS)
Upto 4 years
Time From Randomisation to Second Progression (PFS2)
Up to 4 years
Time From Randomisation to Second Subsequent Therapy or Death (TSST)
Up to 4 years
Time From Randomisation to First Subsequent Therapy or Death (TFST)
Up to 4 years
Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
Up to 4 years
- +4 more secondary outcomes
Study Arms (2)
Olaparib
EXPERIMENTALOlaparib tablets po. 300 mg twice daily
Placebo
PLACEBO COMPARATORPlacebo tablets twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Myriad Genetic Laboratories, Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (103)
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Orange, California, 92868, United States
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Stanford, California, 94305-5720, United States
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Aurora, Colorado, 80045, United States
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New Haven, Connecticut, 06510, United States
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Boca Raton, Florida, 33486, United States
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Miami, Florida, 33136, United States
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Chicago, Illinois, 60637, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02215, United States
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St Louis, Missouri, 63110, United States
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Commack, New York, 11725, United States
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New York, New York, 10016, United States
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New York, New York, 10022, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Columbus, Ohio, 43210, United States
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Philadelphia, Pennsylvania, 19111, United States
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Houston, Texas, 77030, United States
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Seattle, Washington, 98104, United States
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Campbelltown, 2560, Australia
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Randwick, 2031, Australia
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St Leonards, 2065, Australia
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Antwerp, 2020, Belgium
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Brussels, 1070, Belgium
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Leuven, 3000, Belgium
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London, Ontario, N6A 4L6, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Sherbrooke, Quebec, J1G 2E8, Canada
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Toronto, M5G 2M9, Canada
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Amiens, 80054, France
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Besançon, 25000, France
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Bordeaux, 33075, France
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Brest, 29609, France
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Clichy, 92118, France
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La Roche-sur-Yon, 85925, France
Research Site
Lille, 59020, France
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Lyon, 69437, France
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Nice, 06189, France
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Paris, 75014, France
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Paris, 75674, France
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Poitiers, 86021, France
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Strasbourg, 67065, France
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Toulouse, 31059, France
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Villejuif, 94800, France
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Berlin, 10967, Germany
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Berlin, D-13353, Germany
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Bochum, 44791, Germany
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Bonn, 53127, Germany
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Dresden, 01307, Germany
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Frankfurt am Main, 60596, Germany
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Hamburg, 20246, Germany
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Hamburg, 22291, Germany
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Hanover, 30625, Germany
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Leipzig, 04103, Germany
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München, 81675, Germany
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Schweinfurt, 97422, Germany
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Ulm, 89081, Germany
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Beersheba, 84101, Israel
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Haifa, 3109601, Israel
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Holon, 58100, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 5265601, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
Research Site
Zefir, 7030000, Israel
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Bologna, 40138, Italy
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Milan, 20132, Italy
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Milan, 20133, Italy
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Padua, 35128, Italy
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Parma, 43126, Italy
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Pescara, 65100, Italy
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Roma, 00128, Italy
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Roma, 00144, Italy
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San Giovanni Rotondo, 71013, Italy
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Verona, 37134, Italy
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Amsterdam, 1105 AZ, Netherlands
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Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 6351, South Korea
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Barcelona, 08035, Spain
Research Site
Girona, 17007, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28007, Spain
Research Site
Madrid, 28034, Spain
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Madrid, 28041, Spain
Research Site
Madrid, 28050, Spain
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Málaga, 29010, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Sabadell, 8208, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46009, Spain
Research Site
Zaragoza, 50009, Spain
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Edinburgh, EH4 2XR, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Liverpool, L69 3GA, United Kingdom
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London, SE5 9RS, United Kingdom
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London, WC1E 6AG, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Surrey, SM1 2DL, United Kingdom
Related Publications (8)
Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.
PMID: 31157963BACKGROUNDKindler HL, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, Bordia S, McGuinness D, Cui K, Locker GY, Golan T. Overall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germline BRCA-Mutated Metastatic Pancreatic Cancer. J Clin Oncol. 2022 Dec 1;40(34):3929-3939. doi: 10.1200/JCO.21.01604. Epub 2022 Jul 14.
PMID: 35834777DERIVEDAmin S, Joo S, Nolte S, Yoo HK, Patel N, Byrnes HF, Costa-Cabral S, Johnson CD. Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values. BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.
PMID: 35596182DERIVEDLi N, Zheng H, Huang Y, Zheng B, Cai H, Liu M. Cost-Effectiveness Analysis of Olaparib Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer. Front Pharmacol. 2021 Apr 20;12:632818. doi: 10.3389/fphar.2021.632818. eCollection 2021.
PMID: 33959007DERIVEDZhan M, Zheng H, Yang Y, He Z, Xu T, Li Q. Cost-Effectiveness Analysis of Maintenance Olaparib in Patients with Metastatic Pancreatic Cancer and a Germline BRCA1/2 Mutation Based on the POLO Trial. Cancer Manag Res. 2020 Dec 16;12:12919-12926. doi: 10.2147/CMAR.S283169. eCollection 2020.
PMID: 33364840DERIVEDGolan T, Kindler HL, Park JO, Reni M, Macarulla T, Hammel P, Van Cutsem E, Arnold D, Hochhauser D, McGuinness D, Locker GY, Goranova T, Schatz P, Liu YZ, Hall MJ. Geographic and Ethnic Heterogeneity of Germline BRCA1 or BRCA2 Mutation Prevalence Among Patients With Metastatic Pancreatic Cancer Screened for Entry Into the POLO Trial. J Clin Oncol. 2020 May 1;38(13):1442-1454. doi: 10.1200/JCO.19.01890. Epub 2020 Feb 19.
PMID: 32073954DERIVEDHammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. doi: 10.1093/annonc/mdz406.
PMID: 31562758DERIVEDLowery MA, Kelsen DP, Capanu M, Smith SC, Lee JW, Stadler ZK, Moore MJ, Kindler HL, Golan T, Segal A, Maynard H, Hollywood E, Moynahan M, Salo-Mullen EE, Do RKG, Chen AP, Yu KH, Tang LH, O'Reilly EM. Phase II trial of veliparib in patients with previously treated BRCA-mutated pancreas ductal adenocarcinoma. Eur J Cancer. 2018 Jan;89:19-26. doi: 10.1016/j.ejca.2017.11.004. Epub 2017 Dec 8.
PMID: 29223478DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- AstraZeneca AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2014
First Posted
July 9, 2014
Study Start
December 16, 2014
Primary Completion
January 15, 2019
Study Completion
January 27, 2023
Last Updated
September 13, 2023
Results First Posted
January 27, 2020
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.