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Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924533
Recruitment Status : Active, not recruiting
First Posted : August 16, 2013
Results First Posted : November 7, 2018
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
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
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
Hide 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
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2 Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
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.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
>=18 - <50 Number Analyzed 263 participants 262 participants 525 participants
68
  25.9%
64
  24.4%
132
  25.1%
>=50 - <65 Number Analyzed 263 participants 262 participants 525 participants
115
  43.7%
128
  48.9%
243
  46.3%
>=65 Number Analyzed 263 participants 262 participants 525 participants
80
  30.4%
70
  26.7%
150
  28.6%
Age, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
>=18 - <50 Number Analyzed 48 participants 46 participants 94 participants
12
  25.0%
7
  15.2%
19
  20.2%
>=50 - <65 Number Analyzed 48 participants 46 participants 94 participants
22
  45.8%
24
  52.2%
46
  48.9%
>=65 Number Analyzed 48 participants 46 participants 94 participants
14
  29.2%
15
  32.6%
29
  30.9%
[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.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 262 participants 525 participants
Female
89
  33.8%
77
  29.4%
166
  31.6%
Male
174
  66.2%
185
  70.6%
359
  68.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic Or Latino Number Analyzed 263 participants 262 participants 525 participants
263
 100.0%
262
 100.0%
525
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 263 participants 262 participants 525 participants
263
 100.0%
262
 100.0%
525
 100.0%
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 48 participants 46 participants 94 participants
48
 100.0%
46
 100.0%
94
 100.0%
[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.
Race/Ethnicity, Customized   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 48 participants 46 participants 94 participants
48
 100.0%
46
 100.0%
94
 100.0%
[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.
ATM Status  
Measure Type: Number
Unit of measure:  Participants
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
Full Number Analyzed 263 participants 262 participants 525 participants
50
  19.0%
68
  26.0%
118
  22.5%
None Number Analyzed 263 participants 262 participants 525 participants
136
  51.7%
122
  46.6%
258
  49.1%
Partial Number Analyzed 263 participants 262 participants 525 participants
77
  29.3%
72
  27.5%
149
  28.4%
Gastrectomy Status   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Full Number Analyzed 48 participants 46 participants 94 participants
13
  27.1%
13
  28.3%
26
  27.7%
Partial Number Analyzed 48 participants 46 participants 94 participants
19
  39.6%
12
  26.1%
31
  33.0%
None Number Analyzed 48 participants 46 participants 94 participants
16
  33.3%
21
  45.7%
37
  39.4%
[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.
1.Primary Outcome
Title Overall Survival
Hide Description Time from the date of randomization until death due to any cause
Time Frame Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 263 262
Measure Type: Number
Unit of Measure: participants
82 62
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0262
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.79
Confidence Interval (2-Sided) 97.5%
0.63 to 1.00
Estimation Comments [Not Specified]
2.Primary Outcome
Title Overall Survival
Hide Description Time from the date of randomization until death due to any cause
Time Frame Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: participants
19 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2458
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 97.5%
0.40 to 1.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 263 262
Measure Type: Number
Unit of Measure: participants
47 29
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0645
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 97.5%
0.67 to 1.04
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS analysis set - ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: participants
11 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2199
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 97.5%
0.42 to 1.29
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With Objective Response.
Hide Description Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 263 262
Measure Type: Number
Unit of Measure: participants
44 28
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0548
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.69
Confidence Interval (2-Sided) 97.5%
0.92 to 3.17
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients Objective Response
Hide Description Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 48 46
Measure Type: Number
Unit of Measure: participants
12 5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0309
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.24
Confidence Interval (2-Sided) 97.5%
0.95 to 23.23
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale
Hide Description Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration
Time Frame Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose baseline HRQoL score >=10 in full analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 240 249
Measure Type: Number
Unit of Measure: participants
160 177
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0716
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 97.5%
0.64 to 1.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale
Hide Description Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration
Time Frame Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients whose baseline HRQoL score >=10 in full analysis set ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 41 43
Measure Type: Number
Unit of Measure: participants
29 33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2, Placebo Tablets bd + Paclitaxel 80 mg/m^2
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0927
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 97.5%
0.34 to 1.16
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time to Response
Hide Description Time from randomization to the first onset of a confirmed objective tumour response
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with objective response in full analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 44 28
Median (Inter-Quartile Range)
Unit of Measure: days
57.0
(54.5 to 64.0)
57.0
(56.0 to 111.5)
10.Secondary Outcome
Title Time to Response
Hide Description Time from randomization to the first onset of a confirmed objective tumour response
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with objective response in full analysis set ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 12 5
Median (Inter-Quartile Range)
Unit of Measure: days
57.5
(57.0 to 113.0)
57.0
(55.0 to 58.0)
11.Secondary Outcome
Title Duration of Response
Hide Description Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with objective response in full analysis set population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 44 28
Median (Inter-Quartile Range)
Unit of Measure: days
166.0
(89.0 to 218.0)
64.0
(54.0 to 186.0)
12.Secondary Outcome
Title Duration of Response
Hide Description Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits
Time Frame Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with objective response in full analysis set ATM negative population
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description:
Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2
Placebo tablets bd + Paclitaxel 80 mg/m^2
Overall Number of Participants Analyzed 12 5
Median (Inter-Quartile Range)
Unit of Measure: days
171.0
(124.0 to 350.0)
108.0
(57.0 to 113.0)
Time Frame [Not Specified]
Adverse Event Reporting Description Participants in the Full Analysis Set (i.e., 263 and 262) were monitored/assessed for All-Cause Mortality/Overall Survival and participants in the Safety Set (i.e., 262 and 259) were monitored/assessed for Serious and Other (Not Including Serious) Adverse Events.
 
Arm/Group Title Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Hide Arm/Group Description Olaparib 100 mg tablets bd + Paclitaxel 80 mg/m^2 Placebo tablets bd + Paclitaxel 80 mg/m^2
All-Cause Mortality
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Affected / at Risk (%) Affected / at Risk (%)
Total   181/263 (68.82%)      200/262 (76.34%)    
Hide Serious Adverse Events
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/262 (35.11%)      65/259 (25.10%)    
Blood and lymphatic system disorders     
Anaemia  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Bone marrow disorder  1  6/262 (2.29%)  7 3/259 (1.16%)  4
Disseminated intravascular coagulation  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Febrile neutropenia  1  5/262 (1.91%)  5 2/259 (0.77%)  2
Granulocytopenia  1  5/262 (1.91%)  6 2/259 (0.77%)  2
Leukopenia  1  5/262 (1.91%)  5 0/259 (0.00%)  0
Neutropenia  1  1/262 (0.38%)  1 2/259 (0.77%)  2
Cardiac disorders     
Cardiac arrest  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Cardiac failure  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Ear and labyrinth disorders     
Hypoacusis  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Gastrointestinal disorders     
Abdominal pain  1  4/262 (1.53%)  5 3/259 (1.16%)  3
Ascites  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Diarrhoea  1  2/262 (0.76%)  2 1/259 (0.39%)  1
Dyspepsia  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Dysphagia  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Gastric haemorrhage  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Gastrointestinal haemorrhage  1  1/262 (0.38%)  1 2/259 (0.77%)  2
Gastrooesophageal reflux disease  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Haematemesis  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Haematochezia  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Ileus  1  4/262 (1.53%)  4 4/259 (1.54%)  5
Intestinal dilatation  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Intestinal obstruction  1  3/262 (1.15%)  3 1/259 (0.39%)  1
Melaena  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Nausea  1  3/262 (1.15%)  4 1/259 (0.39%)  1
Obstruction gastric  1  1/262 (0.38%)  1 1/259 (0.39%)  2
Oesophageal obstruction  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Vomiting  1  4/262 (1.53%)  4 4/259 (1.54%)  4
General disorders     
Asthenia  1  2/262 (0.76%)  2 2/259 (0.77%)  2
Chest pain  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Death  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Fatigue  1  2/262 (0.76%)  2 1/259 (0.39%)  1
Multiple organ dysfunction syndrome  1  0/262 (0.00%)  0 2/259 (0.77%)  2
Pyrexia  1  4/262 (1.53%)  5 4/259 (1.54%)  4
Hepatobiliary disorders     
Bile duct stenosis  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Bile duct stone  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Cholangitis  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Cholangitis acute  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Cholecystitis  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Dilatation intrahepatic duct acquired  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Hepatic function abnormal  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Jaundice cholestatic  1  3/262 (1.15%)  3 0/259 (0.00%)  0
Liver injury  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Infections and infestations     
Abdominal infection  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Atypical mycobacterial infection  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Biliary tract infection  1  1/262 (0.38%)  2 0/259 (0.00%)  0
Bronchiolitis  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Bronchitis  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Device related infection  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Enterocolitis infectious  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Gastroenteritis  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Lung infection  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Pneumonia  1  6/262 (2.29%)  6 4/259 (1.54%)  4
Scrub typhus  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Sepsis  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Upper respiratory tract infection  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Urinary tract infection  1  2/262 (0.76%)  2 1/259 (0.39%)  1
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Gastrointestinal anastomotic leak  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Humerus fracture  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Splenic rupture  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Subdural haematoma  1  0/262 (0.00%)  0 1/259 (0.39%)  3
Investigations     
Alanine aminotransferase increased  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Aspartate aminotransferase increased  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Blood bilirubin increased  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Coagulation test abnormal  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Granulocyte count decreased  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Neutrophil count decreased  1  1/262 (0.38%)  2 0/259 (0.00%)  0
Weight decreased  1  0/262 (0.00%)  0 1/259 (0.39%)  1
White blood cell count decreased  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Decreased appetite  1  2/262 (0.76%)  3 0/259 (0.00%)  0
Hypoproteinaemia  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Muscular weakness  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal cancer  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Nervous system disorders     
Cerebral haemorrhage  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Dizziness  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Epilepsy  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Headache  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Loss of consciousness  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Optic neuritis  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Syncope  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Product Issues     
Device malfunction  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Stent malfunction  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Psychiatric disorders     
Delirium  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Suicide attempt  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/262 (0.38%)  1 1/259 (0.39%)  1
Calculus bladder  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Haematuria  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Hydronephrosis  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Urinary tract obstruction  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Respiratory, thoracic and mediastinal disorders     
Chylothorax  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Cough  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Dyspnoea  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Interstitial lung disease  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Pleural effusion  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Pneumonia aspiration  1  0/262 (0.00%)  0 2/259 (0.77%)  2
Pneumonitis  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Pneumothorax  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Respiratory failure  1  1/262 (0.38%)  1 0/259 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermal cyst  1  0/262 (0.00%)  0 1/259 (0.39%)  1
Vascular disorders     
Deep vein thrombosis  1  2/262 (0.76%)  2 0/259 (0.00%)  0
Venous thrombosis  1  2/262 (0.76%)  2 0/259 (0.00%)  0
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 100 mg Tablets bd + Paclitaxel 80 mg/m^2 Placebo Tablets bd + Paclitaxel 80 mg/m^2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   257/262 (98.09%)      253/259 (97.68%)    
Blood and lymphatic system disorders     
Anaemia  1  99/262 (37.79%)  156 62/259 (23.94%)  101
Leukopenia  1  71/262 (27.10%)  232 57/259 (22.01%)  177
Neutropenia  1  122/262 (46.56%)  373 108/259 (41.70%)  300
Gastrointestinal disorders     
Abdominal distension  1  19/262 (7.25%)  22 19/259 (7.34%)  20
Abdominal pain  1  23/262 (8.78%)  26 28/259 (10.81%)  33
Abdominal pain upper  1  20/262 (7.63%)  23 15/259 (5.79%)  17
Constipation  1  38/262 (14.50%)  52 50/259 (19.31%)  63
Diarrhoea  1  66/262 (25.19%)  102 51/259 (19.69%)  65
Dyspepsia  1  13/262 (4.96%)  14 13/259 (5.02%)  16
Nausea  1  75/262 (28.63%)  121 63/259 (24.32%)  93
Stomatitis  1  21/262 (8.02%)  32 12/259 (4.63%)  13
Vomiting  1  45/262 (17.18%)  67 43/259 (16.60%)  70
General disorders     
Asthenia  1  45/262 (17.18%)  50 35/259 (13.51%)  51
Fatigue  1  48/262 (18.32%)  70 52/259 (20.08%)  71
Malaise  1  15/262 (5.73%)  41 12/259 (4.63%)  23
Pyrexia  1  34/262 (12.98%)  45 36/259 (13.90%)  59
Infections and infestations     
Nasopharyngitis  1  16/262 (6.11%)  20 9/259 (3.47%)  16
Upper respiratory tract infection  1  19/262 (7.25%)  31 14/259 (5.41%)  16
Investigations     
Alanine aminotransferase increased  1  31/262 (11.83%)  40 14/259 (5.41%)  18
Aspartate aminotransferase increased  1  23/262 (8.78%)  27 16/259 (6.18%)  22
Blood bilirubin increased  1  10/262 (3.82%)  13 14/259 (5.41%)  15
Haemoglobin decreased  1  18/262 (6.87%)  35 20/259 (7.72%)  37
Neutrophil count decreased  1  67/262 (25.57%)  188 38/259 (14.67%)  80
Platelet count decreased  1  20/262 (7.63%)  28 12/259 (4.63%)  18
White blood cell count decreased  1  60/262 (22.90%)  165 48/259 (18.53%)  116
Metabolism and nutrition disorders     
Decreased appetite  1  86/262 (32.82%)  127 69/259 (26.64%)  97
Hypoalbuminaemia  1  14/262 (5.34%)  16 13/259 (5.02%)  16
Hypokalaemia  1  21/262 (8.02%)  25 16/259 (6.18%)  22
Musculoskeletal and connective tissue disorders     
Arthralgia  1  17/262 (6.49%)  21 15/259 (5.79%)  26
Back pain  1  8/262 (3.05%)  9 13/259 (5.02%)  16
Myalgia  1  37/262 (14.12%)  51 35/259 (13.51%)  65
Nervous system disorders     
Dizziness  1  11/262 (4.20%)  14 14/259 (5.41%)  14
Hypoaesthesia  1  20/262 (7.63%)  23 16/259 (6.18%)  18
Neuropathy peripheral  1  41/262 (15.65%)  41 42/259 (16.22%)  45
Peripheral sensory neuropathy  1  41/262 (15.65%)  45 29/259 (11.20%)  30
Psychiatric disorders     
Insomnia  1  20/262 (7.63%)  22 19/259 (7.34%)  36
Respiratory, thoracic and mediastinal disorders     
Cough  1  22/262 (8.40%)  29 24/259 (9.27%)  27
Skin and subcutaneous tissue disorders     
Alopecia  1  112/262 (42.75%)  112 116/259 (44.79%)  117
Pruritus  1  10/262 (3.82%)  13 17/259 (6.56%)  18
Rash  1  35/262 (13.36%)  44 24/259 (9.27%)  29
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Gershon Locker Global Clinical Lead (GCL)
Organization: AstraZeneca
EMail: gershon.locker@astrazeneca.com
Layout table for additonal information
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: June 30, 2021