Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
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ClinicalTrials.gov Identifier: NCT01924533 |
Recruitment Status :
Completed
First Posted : August 16, 2013
Results First Posted : November 7, 2018
Last Update Posted : March 22, 2024
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Gastric Cancer |
Interventions |
Drug: Olaparib Drug: Paclitaxel Drug: Placebo |
Enrollment | 525 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | The number of participants in the participant flow (525) includes all participants who were eligible and assigiend to each treatment group. |
Arm/Group Title | Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | Placebo Tablets bd + Paclitaxel 80 mg/m^2 |
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Arm/Group Description | Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 | Placebo tablets bd + Paclitaxel 80 mg/m^2 |
Period Title: Overall Study | ||
Started | 263 | 262 |
Completed | 74 | 57 |
Not Completed | 189 | 205 |
Reason Not Completed | ||
Death | 181 | 200 |
Lost to Follow-up | 0 | 1 |
Withdrawal by Subject | 7 | 3 |
Other Eligibility criteria | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 | Placebo Tablets bd + Paclitaxel 80 mg/m^2 | Total | |
---|---|---|---|---|
Arm/Group Description | Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 | Placebo tablets bd + Paclitaxel 80 mg/m^2 | Total of all reporting groups | |
Overall Number of Baseline Participants | 263 | 262 | 525 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 263 participants | 262 participants | 525 participants | |
57.1 (11.90) | 57.3 (11.14) | 57.2 (11.52) | ||
Age, Continuous
[1] [2] Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 48 participants | 46 participants | 94 participants | |
57.0 (12.08) | 60.9 (9.90) | 58.9 (11.18) | ||
[1]
Measure Description: ATM Negative Population
[2]
Measure Analysis Population Description: The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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>=18 - <50 | Number Analyzed | 263 participants | 262 participants | 525 participants |
68 25.9%
|
64 24.4%
|
132 25.1%
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>=50 - <65 | Number Analyzed | 263 participants | 262 participants | 525 participants |
115 43.7%
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128 48.9%
|
243 46.3%
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>=65 | Number Analyzed | 263 participants | 262 participants | 525 participants |
80 30.4%
|
70 26.7%
|
150 28.6%
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Age, Customized
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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>=18 - <50 | Number Analyzed | 48 participants | 46 participants | 94 participants |
12 25.0%
|
7 15.2%
|
19 20.2%
|
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>=50 - <65 | Number Analyzed | 48 participants | 46 participants | 94 participants |
22 45.8%
|
24 52.2%
|
46 48.9%
|
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>=65 | Number Analyzed | 48 participants | 46 participants | 94 participants |
14 29.2%
|
15 32.6%
|
29 30.9%
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[1]
Measure Description: ATM Negative Population
[2]
Measure Analysis Population Description: The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 263 participants | 262 participants | 525 participants | |
Female |
89 33.8%
|
77 29.4%
|
166 31.6%
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|
Male |
174 66.2%
|
185 70.6%
|
359 68.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Not Hispanic Or Latino | Number Analyzed | 263 participants | 262 participants | 525 participants |
263 100.0%
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262 100.0%
|
525 100.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Asian | Number Analyzed | 263 participants | 262 participants | 525 participants |
263 100.0%
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262 100.0%
|
525 100.0%
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Race/Ethnicity, Customized
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Not Hispanic or Latino | Number Analyzed | 48 participants | 46 participants | 94 participants |
48 100.0%
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46 100.0%
|
94 100.0%
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[1]
Measure Description: ATM Negative Population
[2]
Measure Analysis Population Description: The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
|
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Race/Ethnicity, Customized
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Asian | Number Analyzed | 48 participants | 46 participants | 94 participants |
48 100.0%
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46 100.0%
|
94 100.0%
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[1]
Measure Description: ATM Negative Population
[2]
Measure Analysis Population Description: The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
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ATM Status
Measure Type: Number Unit of measure: Participants |
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Negative | Number Analyzed | 263 participants | 262 participants | 525 participants |
48 | 46 | 94 | ||
Positive | Number Analyzed | 263 participants | 262 participants | 525 participants |
200 | 196 | 396 | ||
Unknown | Number Analyzed | 263 participants | 262 participants | 525 participants |
15 | 20 | 35 | ||
Gastrectomy Status
Measure Type: Count of Participants Unit of measure: Participants |
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Full | Number Analyzed | 263 participants | 262 participants | 525 participants |
50 19.0%
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68 26.0%
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118 22.5%
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None | Number Analyzed | 263 participants | 262 participants | 525 participants |
136 51.7%
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122 46.6%
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258 49.1%
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Partial | Number Analyzed | 263 participants | 262 participants | 525 participants |
77 29.3%
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72 27.5%
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149 28.4%
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Gastrectomy Status
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Full | Number Analyzed | 48 participants | 46 participants | 94 participants |
13 27.1%
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13 28.3%
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26 27.7%
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Partial | Number Analyzed | 48 participants | 46 participants | 94 participants |
19 39.6%
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12 26.1%
|
31 33.0%
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None | Number Analyzed | 48 participants | 46 participants | 94 participants |
16 33.3%
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21 45.7%
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37 39.4%
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[1]
Measure Description: ATM Negative Population
[2]
Measure Analysis Population Description: The numbers of ATM negative population are 48 and 46 while the numbers of overall population are 263 and 262. ATM negative population is a subset of the overall population.
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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.
At least 60 days prior to submission of any material for publication or presentation, Institution and Principal Investigator (PI) shall jointly provide AstraZeneca with such material for review. If requested in writing by AstraZeneca, Institution and PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of AstraZeneca's request to allow for the filing patent application or preserve its proprietary rights in the information.
Results Point of Contact
Name/Title: | Gershon Locker Global Clinical Lead (GCL) |
Organization: | AstraZeneca |
EMail: | gershon.locker@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01924533 |
Other Study ID Numbers: |
D081BC00004 |
First Submitted: | August 14, 2013 |
First Posted: | August 16, 2013 |
Results First Submitted: | February 27, 2017 |
Results First Posted: | November 7, 2018 |
Last Update Posted: | March 22, 2024 |