Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO)
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| ClinicalTrials.gov Identifier: NCT02184195 |
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Recruitment Status :
Completed
First Posted : July 9, 2014
Results First Posted : January 27, 2020
Last Update Posted : September 13, 2023
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Sponsor:
AstraZeneca
Collaborators:
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Germline BRCA1/2 Mutations and Metastatic Adenocarcinoma of the Pancreas |
| Interventions |
Drug: Olaparib Drug: Placebo |
| Enrollment | 154 |
Participant Flow
| Recruitment Details | This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1). |
| Pre-assignment Details | Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule. |
| Arm/Group Title | Olaparib 300 mg Twice Daily (bd) | Placebo |
|---|---|---|
 Arm/Group Description |
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. |
| Period Title: Overall Study | ||
| Started | 92 | 62 |
| Completed | 19 | 7 |
| Not Completed | 73 | 55 |
| Reason Not Completed | ||
| Patient decision | 5 | 2 |
| Eligibility criteria not fulfilled | 0 | 1 |
| Death | 67 | 44 |
| Lost to Follow-up | 1 | 5 |
| Other | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Olaparib 300 mg Twice Daily (bd) | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. | Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 92 | 62 | 154 | |
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Baseline Analysis Population Description |
Full analysis set consisted of all randomised patients analysed on an intent to treat basis.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 92 participants | 62 participants | 154 participants | |
| 58.2 (10.27) | 56.4 (9.07) | 57.5 (9.81) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 92 participants | 62 participants | 154 participants | |
| Female |
39 42.4%
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31 50.0%
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70 45.5%
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| Male |
53 57.6%
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31 50.0%
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84 54.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 92 participants | 62 participants | 154 participants | |
| Hispanic or Latino |
4 4.3%
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2 3.2%
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6 3.9%
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| Not Hispanic or Latino |
88 95.7%
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60 96.8%
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148 96.1%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 92 participants | 62 participants | 154 participants | |
| American Indian or Alaska Native |
1 1.1%
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0 0.0%
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1 0.6%
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| Asian |
4 4.3%
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2 3.2%
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6 3.9%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
5 5.4%
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0 0.0%
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5 3.2%
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| White |
82 89.1%
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59 95.2%
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141 91.6%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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1 1.6%
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1 0.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
Results Point of Contact
| Name/Title: | Global Clinical Leader |
| Organization: | AstraZeneca AB |
| Phone: | 1-877-240-9479 |
| EMail: | information.center@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02184195 |
| Other Study ID Numbers: |
D081FC00001 2014-001589-85 ( EudraCT Number ) |
| First Submitted: | June 6, 2014 |
| First Posted: | July 9, 2014 |
| Results First Submitted: | January 14, 2020 |
| Results First Posted: | January 27, 2020 |
| Last Update Posted: | September 13, 2023 |