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

Recruitment Status:
Active, not recruiting

Sponsor:
AstraZeneca

Collaborator:
Myriad Genetics - BRCAnalysis test for FDA Premarket Approval (PMA)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT02184195

Verification:
Verified 01 July 2019   by AstraZeneca

History of Changes:
ClinicalTrials.gov

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

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
Study Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:16 December 2014
Study Start Date Type:Actual
Primary Completion Date:15 January 2019
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ConditionInterventionPhase
germline BRCA1/2 mutations and
metastatic adenocarcinoma of the pancreas
Drug: Olaparib
Drug: Olaparib
Drug: Placebo
Drug: Placebo
Phase 3
Ages Eligible for Study: 18 Years  to 99 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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

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

Sponsors and Collaborators

AstraZeneca
Myriad Genetics - BRCAnalysis test for FDA Premarket Approval (PMA)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


Locations

CountryLocationFacilityContactStatus
BelgiumResearch Site Antwerpen, Belgium, 2020Completed
BelgiumResearch Site Brussels (Anderlecht), Belgium, 1070Completed
BelgiumResearch Site Edegem, Belgium, 2650Withdrawn
BelgiumResearch Site Leuven, Belgium, 3000Active, not recruiting
CanadaResearch Site Toronto, Canada, M5G 2M9Completed
GermanyResearch Site Berlin, Germany, 10967Active, not recruiting
GermanyResearch Site Berlin, Germany, D-13353Active, not recruiting
GermanyResearch Site Bochum, Germany, 44791Active, not recruiting
GermanyResearch Site Bonn, Germany, 53127Completed
GermanyResearch Site Dresden, Germany, 01307Completed
GermanyResearch Site Frankfurt am Main, Germany, 60596Completed
GermanyResearch Site Freiburg im Breisgau, Germany, 79106Withdrawn
GermanyResearch Site Hamburg, Germany, 22291Completed
GermanyResearch Site Hamburg, Germany, 20246Completed
GermanyResearch Site Hannover, Germany, 30625Completed
GermanyResearch Site Leipzig, Germany, 04103Completed
GermanyResearch Site München, Germany, 81675Active, not recruiting
GermanyResearch Site Schweinfurt, Germany, 97422Completed
GermanyResearch Site Ulm, Germany, 89081Completed
AustraliaResearch Site Campbelltown, Australia, 2560Completed
AustraliaResearch Site Lilydale, Australia, 3140Withdrawn
AustraliaResearch Site Randwick, Australia, 2031Active, not recruiting
AustraliaResearch Site St Leonards, Australia, 2065Completed
AustraliaResearch Site Woolloongabba, Australia, 4102Withdrawn
Canada , ONResearch Site London, ON, Canada, N6A 4L6Completed
Canada , ONResearch Site Ottawa, ON, Canada, K1H 8L6Withdrawn
FranceResearch Site Amiens, France, 80054Completed
FranceResearch Site Besançon, France, 25030Completed
FranceResearch Site Bordeaux, France, 33075Active, not recruiting
FranceResearch Site Brest Cedex, France, 29609Completed
FranceResearch Site Clichy Cedex, France, 92118Active, not recruiting
FranceResearch Site La Roche sur Yon, France, 85925Completed
FranceResearch Site LILLE, France, 59020Active, not recruiting
FranceResearch Site Lyon, France, 69008Withdrawn
FranceResearch Site LYON CEDEX 03, France, 69437Active, not recruiting
FranceResearch Site Montpellier, France, 34298Withdrawn
FranceResearch Site Nice, France, 06189Completed
FranceResearch Site PARIS, France, 75014Completed
FranceResearch Site Paris CEDEX 14, France, 75674Completed
FranceResearch Site POITIERS, France, 86021Active, not recruiting
FranceResearch Site Rennes, France, 35042Withdrawn
FranceResearch Site STRASBOURG Cedex, France, 67065Completed
FranceResearch Site Toulouse, France, 31059Active, not recruiting
FranceResearch Site Villejuif, France, 94800Active, not recruiting
IsraelResearch Site Beer Sheva, Israel, 84101Completed
IsraelResearch Site Haifa, Israel, 31096Completed
IsraelResearch Site Holon, Israel, 58100Completed
IsraelResearch Site Nahariya, Israel, 22100Active, not recruiting
IsraelResearch Site Petah Tikva, Israel, 49100Active, not recruiting
IsraelResearch Site Ramat Gan, Israel, 5265601Active, not recruiting
IsraelResearch Site Rehovot, Israel, 76100Completed
IsraelResearch Site Tel Aviv, Israel, 64239Active, not recruiting
IsraelResearch Site Zefir, Israel, 7030000Completed
SpainResearch Site Barcelona, Spain, 08035Active, not recruiting
SpainResearch Site Girona, Spain, 17007Active, not recruiting
SpainResearch Site L'Hospitalet de Llobregat, Spain, 08907Completed
SpainResearch Site Madrid, Spain, 28007Completed
SpainResearch Site Madrid, Spain, 28034Completed
SpainResearch Site Madrid, Spain, 28050Completed
SpainResearch Site Madrid, Spain, 28041Active, not recruiting
SpainResearch Site Málaga, Spain, 29010Completed
SpainResearch Site Pamplona, Spain, 31008Active, not recruiting
SpainResearch Site Sabadell, Spain, 8208Completed
SpainResearch Site Santiago de Compostela(A Coru, Spain, 15706Completed
SpainResearch Site Valencia, Spain, 46009Completed
SpainResearch Site Zaragoza, Spain, 50009Completed
United KingdomResearch Site Edinburgh, United Kingdom, EH4 2XUCompleted
United KingdomResearch Site Glasgow, United Kingdom, G12 0YNCompleted
United KingdomResearch Site Leeds, United Kingdom, LS9 7TFWithdrawn
United KingdomResearch Site Liverpool, United Kingdom, L69 3GAActive, not recruiting
United KingdomResearch Site London, United Kingdom, WC1E 6BTCompleted
United KingdomResearch Site London, United Kingdom, SE5 9RSCompleted
United KingdomResearch Site Manchester, United Kingdom, M20 4BXCompleted
United KingdomResearch Site Northwood, United Kingdom, HA6 2RNCompleted
United KingdomResearch Site Nottingham, United Kingdom, NG5 1PBCompleted
United KingdomResearch Site Surrey, United Kingdom, SM1 2DLActive, not recruiting
South KoreaResearch Site Seongnam-si, South Korea, 13620Completed
South KoreaResearch Site Seoul, South Korea, 110-744Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 06351Active, not recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1105 AZActive, not recruiting
NetherlandsResearch Site Maastricht, Netherlands, 6202 AZWithdrawn
United States of America , CAResearch Site Downey, CA, United States of America, 90241Withdrawn
United States of America , CAResearch Site La Jolla, CA, United States of America, 92093Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90048Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90030Withdrawn
United States of America , CAResearch Site Santa Monica, CA, United States of America, 90404Withdrawn
United States of America , CAResearch Site Stanford, CA, United States of America, 94305-5720Active, not recruiting
Canada , QCResearch Site Montreal, QC, Canada, H2X 3J4Withdrawn
Canada , QCResearch Site Sherbrooke, QC, Canada, J1G 2E8Completed
ItalyResearch Site Ancona, Italy, 60126Withdrawn
ItalyResearch Site Bologna, Italy, 40138Completed
ItalyResearch Site Milano, Italy, 20132Active, not recruiting
ItalyResearch Site Milano, Italy, 20133Completed
ItalyResearch Site Monserrato, Italy, 09042Withdrawn
ItalyResearch Site PADOVA, Italy, 35128Completed
ItalyResearch Site Parma, Italy, 43126Completed
ItalyResearch Site Pescara, Italy, 65100Completed
ItalyResearch Site Pisa, Italy, 56126Withdrawn
ItalyResearch Site Roma, Italy, 00144Active, not recruiting
ItalyResearch Site Roma, Italy, 00128Completed
ItalyResearch Site San Giovanni Rotondo, Italy, 71013Active, not recruiting
ItalyResearch Site Verona, Italy, 37134Active, not recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60637Active, not recruiting
United States of America , ILResearch Site Evanston, IL, United States of America, 60201Withdrawn
United States of America , MDResearch Site Baltimore, MD, United States of America, 21287Active, not recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Withdrawn
United States of America , PAResearch Site Philadelphia, PA, United States of America, 19111Completed
United States of America , ConnecticutResearch Site New Haven, Connecticut, United States of America, 06510-3220Completed
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Completed
United States of America , COResearch Site Aurora, CO, United States of America, 80045Completed
United States of America , FLResearch Site Boca Raton, FL, United States of America, 33486Active, not recruiting
United States of America , FLResearch Site Miami, FL, United States of America, 33136Withdrawn
United States of America , FLResearch Site Miami, FL, United States of America, 33136Active, not recruiting
United States of America , NYResearch Site Commack, NY, United States of America, 11725Completed
United States of America , NYResearch Site New York, NY, United States of America, 10032Completed
United States of America , NYResearch Site New York, NY, United States of America, 10022Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10065Completed
United States of America , NYResearch Site Sleepy Hollow, NY, United States of America, 10591Withdrawn
United States of America , NYResearch Site West Harrison, NY, United States of America, 10604Withdrawn
United States of America , MOResearch Site St Louis, MO, United States of America, 63110Completed
United States of America , SCResearch Site Spartenburg, SC, United States of America, 29303Withdrawn
Canada , QuebecResearch Site Montreal, Quebec, Canada, H3T 1E2Completed
United States of America , ArizonaResearch Site Gilbert, Arizona, United States of America, 85234Completed
United States of America , CaliforniaResearch Site Orange, California, United States of America, 92868-3298Completed
United States of America , MAResearch Site Boston, MA, United States of America, 02114-2696Withdrawn
United States of America , MAResearch Site Boston, MA, United States of America, 02215Active, not recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Withdrawn
United States of America , WAResearch Site Seattle, WA, United States of America, 98104Completed
Canada , MBResearch Site Winnipeg, MB, Canada, R2H 2A6Withdrawn
United States of America , TXResearch Site Arlington, TX, United States of America, 76012Withdrawn
United States of America , TXResearch Site Dallas, TX, United States of America, 75390Withdrawn
United States of America , TXResearch Site Houston, TX, United States of America, 77030Active, not recruiting
United States of America , New YorkResearch Site New York City, New York, United States of America, 10015Completed
United States of America , New YorkResearch Site Rockville Centre, New York, United States of America, 11570-1000Withdrawn
United States of America , NJResearch Site Basking Ridge, NJ, United States of America, 07920Withdrawn
United States of America , DCResearch Site Washington, DC, United States of America, 20007Withdrawn

.

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

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
Study Type:Interventional
Overall Recruitment Status:Active, not recruiting
Study Start Date:16 December 2014
Study Start Date Type:Actual
Primary Completion Date:15 January 2019
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
ConditionInterventionPhase
germline BRCA1/2 mutations and
metastatic adenocarcinoma of the pancreas
Drug: Olaparib
Drug: Olaparib
Drug: Placebo
Drug: Placebo
Phase 3
Ages Eligible for Study: 18 Years  to 99 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

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

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

Sponsors and Collaborators

AstraZeneca
Myriad Genetics - BRCAnalysis test for FDA Premarket Approval (PMA)
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


Locations

CountryLocationFacilityContactStatus
BelgiumResearch Site Antwerpen, Belgium, 2020Completed
BelgiumResearch Site Brussels (Anderlecht), Belgium, 1070Completed
BelgiumResearch Site Edegem, Belgium, 2650Withdrawn
BelgiumResearch Site Leuven, Belgium, 3000Active, not recruiting
CanadaResearch Site Toronto, Canada, M5G 2M9Completed
GermanyResearch Site Berlin, Germany, 10967Active, not recruiting
GermanyResearch Site Berlin, Germany, D-13353Active, not recruiting
GermanyResearch Site Bochum, Germany, 44791Active, not recruiting
GermanyResearch Site Bonn, Germany, 53127Completed
GermanyResearch Site Dresden, Germany, 01307Completed
GermanyResearch Site Frankfurt am Main, Germany, 60596Completed
GermanyResearch Site Freiburg im Breisgau, Germany, 79106Withdrawn
GermanyResearch Site Hamburg, Germany, 22291Completed
GermanyResearch Site Hamburg, Germany, 20246Completed
GermanyResearch Site Hannover, Germany, 30625Completed
GermanyResearch Site Leipzig, Germany, 04103Completed
GermanyResearch Site München, Germany, 81675Active, not recruiting
GermanyResearch Site Schweinfurt, Germany, 97422Completed
GermanyResearch Site Ulm, Germany, 89081Completed
AustraliaResearch Site Campbelltown, Australia, 2560Completed
AustraliaResearch Site Lilydale, Australia, 3140Withdrawn
AustraliaResearch Site Randwick, Australia, 2031Active, not recruiting
AustraliaResearch Site St Leonards, Australia, 2065Completed
AustraliaResearch Site Woolloongabba, Australia, 4102Withdrawn
Canada , ONResearch Site London, ON, Canada, N6A 4L6Completed
Canada , ONResearch Site Ottawa, ON, Canada, K1H 8L6Withdrawn
FranceResearch Site Amiens, France, 80054Completed
FranceResearch Site Besançon, France, 25030Completed
FranceResearch Site Bordeaux, France, 33075Active, not recruiting
FranceResearch Site Brest Cedex, France, 29609Completed
FranceResearch Site Clichy Cedex, France, 92118Active, not recruiting
FranceResearch Site La Roche sur Yon, France, 85925Completed
FranceResearch Site LILLE, France, 59020Active, not recruiting
FranceResearch Site Lyon, France, 69008Withdrawn
FranceResearch Site LYON CEDEX 03, France, 69437Active, not recruiting
FranceResearch Site Montpellier, France, 34298Withdrawn
FranceResearch Site Nice, France, 06189Completed
FranceResearch Site PARIS, France, 75014Completed
FranceResearch Site Paris CEDEX 14, France, 75674Completed
FranceResearch Site POITIERS, France, 86021Active, not recruiting
FranceResearch Site Rennes, France, 35042Withdrawn
FranceResearch Site STRASBOURG Cedex, France, 67065Completed
FranceResearch Site Toulouse, France, 31059Active, not recruiting
FranceResearch Site Villejuif, France, 94800Active, not recruiting
IsraelResearch Site Beer Sheva, Israel, 84101Completed
IsraelResearch Site Haifa, Israel, 31096Completed
IsraelResearch Site Holon, Israel, 58100Completed
IsraelResearch Site Nahariya, Israel, 22100Active, not recruiting
IsraelResearch Site Petah Tikva, Israel, 49100Active, not recruiting
IsraelResearch Site Ramat Gan, Israel, 5265601Active, not recruiting
IsraelResearch Site Rehovot, Israel, 76100Completed
IsraelResearch Site Tel Aviv, Israel, 64239Active, not recruiting
IsraelResearch Site Zefir, Israel, 7030000Completed
SpainResearch Site Barcelona, Spain, 08035Active, not recruiting
SpainResearch Site Girona, Spain, 17007Active, not recruiting
SpainResearch Site L'Hospitalet de Llobregat, Spain, 08907Completed
SpainResearch Site Madrid, Spain, 28007Completed
SpainResearch Site Madrid, Spain, 28034Completed
SpainResearch Site Madrid, Spain, 28050Completed
SpainResearch Site Madrid, Spain, 28041Active, not recruiting
SpainResearch Site Málaga, Spain, 29010Completed
SpainResearch Site Pamplona, Spain, 31008Active, not recruiting
SpainResearch Site Sabadell, Spain, 8208Completed
SpainResearch Site Santiago de Compostela(A Coru, Spain, 15706Completed
SpainResearch Site Valencia, Spain, 46009Completed
SpainResearch Site Zaragoza, Spain, 50009Completed
United KingdomResearch Site Edinburgh, United Kingdom, EH4 2XUCompleted
United KingdomResearch Site Glasgow, United Kingdom, G12 0YNCompleted
United KingdomResearch Site Leeds, United Kingdom, LS9 7TFWithdrawn
United KingdomResearch Site Liverpool, United Kingdom, L69 3GAActive, not recruiting
United KingdomResearch Site London, United Kingdom, WC1E 6BTCompleted
United KingdomResearch Site London, United Kingdom, SE5 9RSCompleted
United KingdomResearch Site Manchester, United Kingdom, M20 4BXCompleted
United KingdomResearch Site Northwood, United Kingdom, HA6 2RNCompleted
United KingdomResearch Site Nottingham, United Kingdom, NG5 1PBCompleted
United KingdomResearch Site Surrey, United Kingdom, SM1 2DLActive, not recruiting
South KoreaResearch Site Seongnam-si, South Korea, 13620Completed
South KoreaResearch Site Seoul, South Korea, 110-744Active, not recruiting
South KoreaResearch Site Seoul, South Korea, 06351Active, not recruiting
NetherlandsResearch Site Amsterdam, Netherlands, 1105 AZActive, not recruiting
NetherlandsResearch Site Maastricht, Netherlands, 6202 AZWithdrawn
United States of America , CAResearch Site Downey, CA, United States of America, 90241Withdrawn
United States of America , CAResearch Site La Jolla, CA, United States of America, 92093Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90048Withdrawn
United States of America , CAResearch Site Los Angeles, CA, United States of America, 90030Withdrawn
United States of America , CAResearch Site Santa Monica, CA, United States of America, 90404Withdrawn
United States of America , CAResearch Site Stanford, CA, United States of America, 94305-5720Active, not recruiting
Canada , QCResearch Site Montreal, QC, Canada, H2X 3J4Withdrawn
Canada , QCResearch Site Sherbrooke, QC, Canada, J1G 2E8Completed
ItalyResearch Site Ancona, Italy, 60126Withdrawn
ItalyResearch Site Bologna, Italy, 40138Completed
ItalyResearch Site Milano, Italy, 20132Active, not recruiting
ItalyResearch Site Milano, Italy, 20133Completed
ItalyResearch Site Monserrato, Italy, 09042Withdrawn
ItalyResearch Site PADOVA, Italy, 35128Completed
ItalyResearch Site Parma, Italy, 43126Completed
ItalyResearch Site Pescara, Italy, 65100Completed
ItalyResearch Site Pisa, Italy, 56126Withdrawn
ItalyResearch Site Roma, Italy, 00144Active, not recruiting
ItalyResearch Site Roma, Italy, 00128Completed
ItalyResearch Site San Giovanni Rotondo, Italy, 71013Active, not recruiting
ItalyResearch Site Verona, Italy, 37134Active, not recruiting
United States of America , ILResearch Site Chicago, IL, United States of America, 60637Active, not recruiting
United States of America , ILResearch Site Evanston, IL, United States of America, 60201Withdrawn
United States of America , MDResearch Site Baltimore, MD, United States of America, 21287Active, not recruiting
United States of America , MDResearch Site Bethesda, MD, United States of America, 20889Withdrawn
United States of America , PAResearch Site Philadelphia, PA, United States of America, 19111Completed
United States of America , ConnecticutResearch Site New Haven, Connecticut, United States of America, 06510-3220Completed
United States of America , OHResearch Site Columbus, OH, United States of America, 43210Completed
United States of America , COResearch Site Aurora, CO, United States of America, 80045Completed
United States of America , FLResearch Site Boca Raton, FL, United States of America, 33486Active, not recruiting
United States of America , FLResearch Site Miami, FL, United States of America, 33136Withdrawn
United States of America , FLResearch Site Miami, FL, United States of America, 33136Active, not recruiting
United States of America , NYResearch Site Commack, NY, United States of America, 11725Completed
United States of America , NYResearch Site New York, NY, United States of America, 10032Completed
United States of America , NYResearch Site New York, NY, United States of America, 10022Active, not recruiting
United States of America , NYResearch Site New York, NY, United States of America, 10065Completed
United States of America , NYResearch Site Sleepy Hollow, NY, United States of America, 10591Withdrawn
United States of America , NYResearch Site West Harrison, NY, United States of America, 10604Withdrawn
United States of America , MOResearch Site St Louis, MO, United States of America, 63110Completed
United States of America , SCResearch Site Spartenburg, SC, United States of America, 29303Withdrawn
Canada , QuebecResearch Site Montreal, Quebec, Canada, H3T 1E2Completed
United States of America , ArizonaResearch Site Gilbert, Arizona, United States of America, 85234Completed
United States of America , CaliforniaResearch Site Orange, California, United States of America, 92868-3298Completed
United States of America , MAResearch Site Boston, MA, United States of America, 02114-2696Withdrawn
United States of America , MAResearch Site Boston, MA, United States of America, 02215Active, not recruiting
United States of America , WAResearch Site Seattle, WA, United States of America, 98109Withdrawn
United States of America , WAResearch Site Seattle, WA, United States of America, 98104Completed
Canada , MBResearch Site Winnipeg, MB, Canada, R2H 2A6Withdrawn
United States of America , TXResearch Site Arlington, TX, United States of America, 76012Withdrawn
United States of America , TXResearch Site Dallas, TX, United States of America, 75390Withdrawn
United States of America , TXResearch Site Houston, TX, United States of America, 77030Active, not recruiting
United States of America , New YorkResearch Site New York City, New York, United States of America, 10015Completed
United States of America , New YorkResearch Site Rockville Centre, New York, United States of America, 11570-1000Withdrawn
United States of America , NJResearch Site Basking Ridge, NJ, United States of America, 07920Withdrawn
United States of America , DCResearch Site Washington, DC, United States of America, 20007Withdrawn

Oversight


Is FDA regulated intervention: Yes 
Is IND/IDE protocol: Yes 
Section 801 trial: Yes 
Delayed Posting: No 
IND/IDE Grantor: CDER 
IND/IDE Number: 121412 
Has Expanded Access: No 

More Information


https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081FC00001&attachmentIdentifier=9095e288-3d26-4c56-87dd-5dedc61f25c2&fileName=POLO_Revised_CSP_2-24Jul2019_Redacted.pdf&versionIdentifier=

Publications:


Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT02184195
Other Study ID Numbers:D081FC00001, 2014-001589-85
Health Authority:United States: Food and Drug Administration
Australia: National Health and Medical Research Council
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Canadian Institutes of Health Research
Israel: Israeli Health Ministry Pharmaceutical Administration
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Korea: Food and Drug Administration

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

Additional Relevant MeSH terms:
germline BRCA1/2 mutations andmetastatic adenocarcinoma of the pancreas

Primary Outcome Measures:

  • Progression free survival (PFS) by central review of modified RECIST 1.1 [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

ArmsAssigned 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