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Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian 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: NCT00753545
Recruitment Status : Active, not recruiting
First Posted : September 16, 2008
Results First Posted : March 11, 2013
Last Update Posted : September 14, 2020
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 Ovarian Cancer
Interventions Drug: AZD2281
Drug: matching placebo
Enrollment 265
Recruitment Details The first patient was enrolled on 28 August 2008 and the last patient was enrolled on 9 February 2010. Patients were enrolled at 82 centres in 16 countries. Of the 326 patients enrolled, 265 were randomized
Pre-assignment Details It was planned that 250 women with advanced platinum sensitive serous ovarian cancer who had received 2 or more previous platinum-containing regimens and demonstrated an objective stable maintained response in the last platinum regimen prior to enrolment were to receive olaparib 400 mg bd or matching placebo in a 1:1 ratio. 265 randomised.
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily olaparib matching placebo oral capsules twice daily
Period Title: Overall Study
Started 136 [1] 129 [1]
Completed 28 [2] 11 [2]
Not Completed 108 118
Reason Not Completed
Death             98             112
Lost to Follow-up             2             3
Protocol Violation             1             0
Voluntary Discontinuation of Patient             7             3
[1]
Patients randomized
[2]
Patients completing the Study
Arm/Group Title Olaparib 400 mg bd Placebo bd Total
Hide Arm/Group Description AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily olaparib matching placebo oral capsules twice daily Total of all reporting groups
Overall Number of Baseline Participants 136 129 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 129 participants 265 participants
58.9  (10.95) 58.5  (9.89) 58.7  (10.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 129 participants 265 participants
Female
136
 100.0%
129
 100.0%
265
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Time to progression   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 129 participants 265 participants
>6 to 12 months 53 54 107
>12 months 83 75 158
[1]
Measure Description: The time to disease progression from the completion of the penultimate platinum containing therapy (last dose) prior to enrolment on the study.
Objective response   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 136 participants 129 participants 265 participants
Complete response 57 63 120
Partial response 79 66 145
[1]
Measure Description:

Objective response to the last platinum containing regimen prior to enrolment on the study:

  • CR-Complete Response (defined as normal radiological findings and CA-125 within the normal range)
  • PR-Partial Response (defined as a RECIST PR and/or GCIG CA-125 response)
1.Primary Outcome
Title Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
Hide Description PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Median (95% Confidence Interval)
Unit of Measure: Months
8.4
(7.4 to 11.5)
4.8
(4.0 to 5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.25 to 0.49
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
Time Frame Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Median (95% Confidence Interval)
Unit of Measure: Months
29.8
(26.9 to 35.7)
27.8
(24.9 to 33.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.55 to 0.95
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR) (According to RECIST)
Hide Description For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 57 48
Measure Type: Number
Unit of Measure: percentage of participants
12.3 4.2
4.Secondary Outcome
Title Disease Control Rate
Hide Description Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]
Time Frame Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Measure Type: Number
Unit of Measure: percentage of participants
53.7 25.6
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Median (95% Confidence Interval)
Unit of Measure: Months
4.2
(2.8 to 5.6)
2.3
(1.8 to 2.8)
6.Secondary Outcome
Title Percentage Change From Baseline in Tumour Size at Week 24
Hide Description Percentage change from baseline to Week 24 in target tumour size.
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for response set - A subset of the full analysis set which includes patients with measurable disease at baseline.
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 56 47
Least Squares Mean (Full Range)
Unit of Measure: Percent change in tumour size
-0.8
(-100.0 to 45.0)
26.4
(-36.4 to 39.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments LS mean < 0 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03185
Comments [Not Specified]
Method ANCOVA
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Difference in LS means
Estimated Value -27.1
Confidence Interval (2-Sided) 95%
-51.9 to -2.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Hide Description Best percentage change from baseline in CA-125 level
Time Frame CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of the FAS with baseline and at least 1 follow-up value of CA-125
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 135 128
Median (Full Range)
Unit of Measure: percentage of change
-16.67
(-100.00 to 346.15)
0.00
(-99.50 to 1436.84)
8.Secondary Outcome
Title Best Objective Response
Hide Description Best overall response from radiologic assessments. [FAS]
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Measure Type: Number
Unit of Measure: Participants
Complete Response 0 0
Partial Response 7 2
No evidence of disease 49 42
Stable Disease >= 11 weeks 46 25
Disease Progression 24 55
Not Evaluable 10 5
9.Secondary Outcome
Title RECIST and CA-125 Response Separately and Combined
Hide Description RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 61 53
Measure Type: Number
Unit of Measure: Participants
RECIST Response 16 2
Confirmed RECIST Response 7 2
Unconfirmed RECIST response 9 0
CA-125 Response 1 1
Confirmed RECIST or CA-125 Response 8 3
10.Secondary Outcome
Title Time to Earlier of CA-125 or RECIST Progression
Hide Description Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]
Time Frame Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 136 129
Median (95% Confidence Interval)
Unit of Measure: Months
8.3
(5.5 to 10.3)
3.7
(2.8 to 4.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0.25 to 0.47
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Improvement Rate for FACT-O Symptom Index (FOSI)
Hide Description The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for FOSI set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 117 115
Measure Type: Number
Unit of Measure: percentage of evaluable participants
17.1 14.8
12.Secondary Outcome
Title Improvement Rate for Trial Outcome Index (TOI)
Hide Description The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for TOI - a subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 115 111
Measure Type: Number
Unit of Measure: percentage of evaluable participants
20.0 18.0
13.Secondary Outcome
Title Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Hide Description The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable for Total Fact-O set - A subset of the full analysis set which includes patients who have evaluable QoL/Symptom Endpoints at baseline
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 114 111
Measure Type: Number
Unit of Measure: percentage of evaluable participants
21.1 18.9
14.Secondary Outcome
Title FACT-O Symptom Index (FOSI) Time to Worsening
Hide Description The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 117 115
Median (95% Confidence Interval)
Unit of Measure: Months
2.8
(1.8 to 3.7)
3.7
(3.3 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.88 to 1.71
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Trial Outcome Index(TOI)Time to Worsening
Hide Description The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 115 111
Median (95% Confidence Interval)
Unit of Measure: Months
3.8
(2.8 to 7.4)
4.6
(3.7 to 7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.75 to 1.56
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
Hide Description The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
Time Frame Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Olaparib 400 mg bd Placebo bd
Hide Arm/Group Description:
AZD2281 olaparib (AZD2281) 400 mg oral capsules twice daily
olaparib matching placebo oral capsules twice daily
Overall Number of Participants Analyzed 114 111
Median (95% Confidence Interval)
Unit of Measure: Months
2.8
(1.9 to 4.7)
4.6
(3.6 to 5.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olaparib 400 mg bd, Placebo bd
Comments HR < 1 favours olaparib
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Regression, Cox
Comments The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.83 to 1.64
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description 128 participants in Placebo as 1 participant withdrew consent prior to treatment
 
Arm/Group Title Olaparib 400 mg bd Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Olaparib 400 mg bd Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Olaparib 400 mg bd Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/136 (22.79%)      11/128 (8.59%)    
Blood and lymphatic system disorders     
ANAEMIA  1  3/136 (2.21%)  3 0/128 (0.00%)  0
PANCYTOPENIA  1  2/136 (1.47%)  2 0/128 (0.00%)  0
THROMBOCYTOPENIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Cardiac disorders     
CARDIOVASCULAR INSUFFICIENCY  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL INCARCERATED HERNIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
ABDOMINAL PAIN  1  0/136 (0.00%)  0 1/128 (0.78%)  2
CONSTIPATION  1  2/136 (1.47%)  2 0/128 (0.00%)  0
DIARRHOEA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
GASTRITIS  1  0/136 (0.00%)  0 2/128 (1.56%)  2
IMPAIRED GASTRIC EMPTYING  1  0/136 (0.00%)  0 1/128 (0.78%)  1
INTESTINAL OBSTRUCTION  1  1/136 (0.74%)  1 1/128 (0.78%)  1
INTRA-ABDOMINAL HAEMORRHAGE  1  1/136 (0.74%)  1 0/128 (0.00%)  0
MELAENA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
NAUSEA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
SMALL INTESTINAL OBSTRUCTION  1  2/136 (1.47%)  2 3/128 (2.34%)  4
VOMITING  1  1/136 (0.74%)  1 0/128 (0.00%)  0
General disorders     
HERNIA PAIN  1  1/136 (0.74%)  1 0/128 (0.00%)  0
NON-CARDIAC CHEST PAIN  1  1/136 (0.74%)  1 0/128 (0.00%)  0
PYREXIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Immune system disorders     
IODINE ALLERGY  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Infections and infestations     
APPENDICITIS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
ENDOPHTHALMITIS  1  0/136 (0.00%)  0 1/128 (0.78%)  1
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE  1  0/136 (0.00%)  0 1/128 (0.78%)  1
INFLUENZA  1  0/136 (0.00%)  0 1/128 (0.78%)  1
LIVER ABSCESS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
PNEUMONIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  1/136 (0.74%)  1 0/128 (0.00%)  0
URINARY TRACT INFECTION  1  1/136 (0.74%)  1 1/128 (0.78%)  1
Injury, poisoning and procedural complications     
FEMUR FRACTURE  1  2/136 (1.47%)  2 0/128 (0.00%)  0
HIP FRACTURE  1  1/136 (0.74%)  1 0/128 (0.00%)  0
POST PROCEDURAL HAEMATOMA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Metabolism and nutrition disorders     
DEHYDRATION  1  0/136 (0.00%)  0 1/128 (0.78%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
BACK PAIN  1  1/136 (0.74%)  1 0/128 (0.00%)  0
OSTEOPOROSIS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ACUTE LEUKAEMIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
BLADDER CANCER  1  0/136 (0.00%)  0 1/128 (0.78%)  1
INTRADUCTAL PROLIFERATIVE BREAST LESION  1  1/136 (0.74%)  1 0/128 (0.00%)  0
PAPILLARY THYROID CANCER  1  1/136 (0.74%)  1 0/128 (0.00%)  0
SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Nervous system disorders     
APHASIA  1  1/136 (0.74%)  1 0/128 (0.00%)  0
HAEMORRHAGIC STROKE  1  1/136 (0.74%)  1 0/128 (0.00%)  0
SYNCOPE  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Psychiatric disorders     
CONFUSIONAL STATE  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  0/136 (0.00%)  0 1/128 (0.78%)  1
BRONCHIECTASIS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
COUGH  1  1/136 (0.74%)  1 0/128 (0.00%)  0
DYSPNOEA  1  2/136 (1.47%)  2 0/128 (0.00%)  0
PULMONARY EMBOLISM  1  1/136 (0.74%)  2 0/128 (0.00%)  0
Vascular disorders     
DEEP VEIN THROMBOSIS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
ESSENTIAL HYPERTENSION  1  0/136 (0.00%)  0 1/128 (0.78%)  1
VENA CAVA THROMBOSIS  1  1/136 (0.74%)  1 0/128 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olaparib 400 mg bd Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   129/136 (94.85%)      111/128 (86.72%)    
Blood and lymphatic system disorders     
ANAEMIA  1  26/136 (19.12%)  32 7/128 (5.47%)  8
NEUTROPENIA  1  7/136 (5.15%)  8 5/128 (3.91%)  7
Gastrointestinal disorders     
ABDOMINAL DISCOMFORT  1  6/136 (4.41%)  7 7/128 (5.47%)  7
ABDOMINAL DISTENSION  1  21/136 (15.44%)  24 11/128 (8.59%)  13
ABDOMINAL PAIN  1  35/136 (25.74%)  44 34/128 (26.56%)  51
ABDOMINAL PAIN LOWER  1  7/136 (5.15%)  7 10/128 (7.81%)  10
ABDOMINAL PAIN UPPER  1  25/136 (18.38%)  28 11/128 (8.59%)  11
CONSTIPATION  1  30/136 (22.06%)  41 14/128 (10.94%)  15
DIARRHOEA  1  36/136 (26.47%)  62 31/128 (24.22%)  39
DYSPEPSIA  1  27/136 (19.85%)  34 11/128 (8.59%)  11
NAUSEA  1  96/136 (70.59%)  128 46/128 (35.94%)  58
STOMATITIS  1  12/136 (8.82%)  15 4/128 (3.13%)  4
VOMITING  1  47/136 (34.56%)  91 18/128 (14.06%)  20
General disorders     
ASTHENIA  1  19/136 (13.97%)  26 12/128 (9.38%)  15
FATIGUE  1  73/136 (53.68%)  92 50/128 (39.06%)  57
OEDEMA PERIPHERAL  1  12/136 (8.82%)  14 6/128 (4.69%)  7
PYREXIA  1  13/136 (9.56%)  16 4/128 (3.13%)  4
Infections and infestations     
NASOPHARYNGITIS  1  21/136 (15.44%)  26 14/128 (10.94%)  17
UPPER RESPIRATORY TRACT INFECTION  1  18/136 (13.24%)  24 8/128 (6.25%)  8
URINARY TRACT INFECTION  1  15/136 (11.03%)  21 6/128 (4.69%)  6
Investigations     
BLOOD CREATININE INCREASED  1  9/136 (6.62%)  10 2/128 (1.56%)  2
Metabolism and nutrition disorders     
DECREASED APPETITE  1  29/136 (21.32%)  34 17/128 (13.28%)  22
HYPOMAGNESAEMIA  1  8/136 (5.88%)  10 9/128 (7.03%)  10
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  24/136 (17.65%)  36 18/128 (14.06%)  19
BACK PAIN  1  25/136 (18.38%)  37 14/128 (10.94%)  16
MUSCLE SPASMS  1  13/136 (9.56%)  20 5/128 (3.91%)  5
MUSCULOSKELETAL PAIN  1  10/136 (7.35%)  10 8/128 (6.25%)  8
MYALGIA  1  7/136 (5.15%)  7 8/128 (6.25%)  9
PAIN IN EXTREMITY  1  12/136 (8.82%)  16 7/128 (5.47%)  8
Nervous system disorders     
DIZZINESS  1  21/136 (15.44%)  28 9/128 (7.03%)  10
DYSGEUSIA  1  22/136 (16.18%)  26 8/128 (6.25%)  8
HEADACHE  1  29/136 (21.32%)  47 17/128 (13.28%)  20
NEUROPATHY PERIPHERAL  1  12/136 (8.82%)  13 3/128 (2.34%)  5
PARAESTHESIA  1  7/136 (5.15%)  9 3/128 (2.34%)  5
Psychiatric disorders     
ANXIETY  1  8/136 (5.88%)  8 5/128 (3.91%)  6
DEPRESSION  1  11/136 (8.09%)  11 9/128 (7.03%)  10
INSOMNIA  1  9/136 (6.62%)  9 9/128 (7.03%)  10
Respiratory, thoracic and mediastinal disorders     
COUGH  1  23/136 (16.91%)  33 13/128 (10.16%)  14
DYSPNOEA  1  17/136 (12.50%)  20 8/128 (6.25%)  8
Skin and subcutaneous tissue disorders     
DRY SKIN  1  3/136 (2.21%)  3 7/128 (5.47%)  7
PRURITUS  1  8/136 (5.88%)  10 3/128 (2.34%)  3
RASH  1  8/136 (5.88%)  8 12/128 (9.38%)  13
Vascular disorders     
HOT FLUSH  1  5/136 (3.68%)  6 16/128 (12.50%)  18
HYPERTENSION  1  10/136 (7.35%)  10 4/128 (3.13%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elizabeth Lowe
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00753545    
Other Study ID Numbers: D0810C00019
First Submitted: September 12, 2008
First Posted: September 16, 2008
Results First Submitted: December 7, 2012
Results First Posted: March 11, 2013
Last Update Posted: September 14, 2020