Trial Outcomes & Findings for Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer (NCT NCT00494234)
NCT ID: NCT00494234
Last Updated: 2024-01-19
Results Overview
The ORR is the percentage of participants whose best tumor response is either complete response (CR) or partial response (PR), according to the RECIST v1.0 criteria. The CR is defined as disappearance of all target lesions (TLs). The PR is defined as at least a 30% decrease in the sum of longest diameters (LD) taking as reference the baseline sum of LD. Percentage of participants with ORR is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)
Results posted on
2024-01-19
Participant Flow
The study was conducted at 13 centers in 5 countries (Australia, Germany, Sweden, UK and the USA).
A total of 54 participants were enrolled in this study.
Participant milestones
| Measure |
Olaparib 100 mg
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
13
|
18
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
| Measure |
Olaparib 100 mg
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Disease progression
|
11
|
8
|
|
Overall Study
Death
|
2
|
1
|
Baseline Characteristics
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Olaparib 100 mg
n=27 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
44.7 Years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
44.7 Years
STANDARD_DEVIATION 10.74 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)Population: The per-protocol (PP) population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
The ORR is the percentage of participants whose best tumor response is either complete response (CR) or partial response (PR), according to the RECIST v1.0 criteria. The CR is defined as disappearance of all target lesions (TLs). The PR is defined as at least a 30% decrease in the sum of longest diameters (LD) taking as reference the baseline sum of LD. Percentage of participants with ORR is reported.
Outcome measures
| Measure |
Olaparib 100 mg
n=24 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=26 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
|
25.0 Percentage of participants
|
42.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)Population: The PP population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
Duration of response is defined as the date of progression per RECIST criteria - the date when CR or PR \[whichever is earliest\] is confirmed + 1. The CR is defined as disappearance of all TLs. The PR is defined as at least a 30% decrease in the sum of LD taking as reference the baseline sum of LD. Duration of response was analyzed for those participants who had OR.
Outcome measures
| Measure |
Olaparib 100 mg
n=6 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=11 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Duration of Response (DoR) to Olaparib
|
140.5 Days
Full Range 55 • Interval 55.0 to 175.0
|
144.0 Days
Full Range 92 • Interval 92.0 to 393.0
|
SECONDARY outcome
Timeframe: From Day 1 of Cycle 3 through study withdrawal (approximately up to 2 years)Population: The PP population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
The CBR is defined as the percentage of participants with a RECIST tumor response of confirmed CR, PR or stable disease (SD) for ≥ 8 weeks +/- 1 week visit window. The CR is defined as disappearance of all TLs. The PR is defined as at least a 30% decrease in the sum of LD taking as reference the baseline sum of LD. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum of LD since the treatment started.
Outcome measures
| Measure |
Olaparib 100 mg
n=24 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=26 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
70.8 Percentage of Participants
95% Confidence Interval 50.8 • Interval 50.8 to 85.1
|
84.6 Percentage of Participants
95% Confidence Interval 66.5 • Interval 66.5 to 93.9
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to 0) through study withdrawal (approximately up to 2 years)Population: The PP population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
The tumor size is defined as the sum of the longest diameters as measured among all target lesions. At each assessment, the percentage change in tumor size is defined as 100 × 1 - (sum of all target lesion diameters at visit/sum of all target lesion diameters at baseline).
Outcome measures
| Measure |
Olaparib 100 mg
n=24 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=26 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Best Percentage Change in Tumor Size
|
-10.14 Best percentage change in tumor size
Interval -68.9 to 286.7
|
-29.43 Best percentage change in tumor size
Interval -100.0 to 26.7
|
SECONDARY outcome
Timeframe: Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)Population: The PP population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those participants who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where participants had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment. PFS was analyzed using Kaplan-Meier estimate.
Outcome measures
| Measure |
Olaparib 100 mg
n=24 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=26 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
122 Days
Interval 67.0 to 167.0
|
193.5 Days
Interval 140.0 to 226.0
|
SECONDARY outcome
Timeframe: Screening (Days -7 to 0), Day 1 Cycle 7 (ie, after completing 6 cycles of treatment) and study withdrawal (approximately up to 2 years).Population: The PP population included all enrolled participants who completed the trial schedule and medication regime without any major deviations to the protocol.
ECOG performance status is used by researchers to assess how a participant's disease is progressing. The scores are: 0=Fully Active, able to carry out work without restrictions; 1=Restricted activity and able to carry out light work or sedentary nature; 2=capable of self-care but unable to carry out work activities; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely Disabled, and totally confined to bed or chair; 5=Dead. Change in ECOG performance status was defined as improved (less than the baseline value), no change (same as at baseline), worsened (greater than the baseline value) or missing (score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.
Outcome measures
| Measure |
Olaparib 100 mg
n=27 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Number of Participants With Improvement in Eastern Co-operative Oncology Group (ECOG) Performance Status Total Score From Baseline
Cycle 7 Day 1
|
1 Participants
|
6 Participants
|
|
Number of Participants With Improvement in Eastern Co-operative Oncology Group (ECOG) Performance Status Total Score From Baseline
Withdrawal visit
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 480 (maximum observed duration)Population: Safety population included all participants who received at least one dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Olaparib 100 mg
n=27 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAE
|
27 Participants
|
27 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAE
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 480 (maximum observed duration)Population: Safety population included all participants who received at least one dose of study drug.
Number of participants with clinically significant changes in vital signs are reported. Vital sign parameters included body temperature, blood pressure, and pulse rate.
Outcome measures
| Measure |
Olaparib 100 mg
n=27 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs From Baseline
Supraventricular arrhythmia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs From Baseline
Tachycardia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 480 (maximum observed duration)Population: Safety population included all participants who received at least one dose of study drug.
Number of participants with at least 2-grade change from baseline to worst toxicity grade in clinical laboratory parameters are reported. Laboratory parameters included hematology, clinical chemistry, and urinalysis.
Outcome measures
| Measure |
Olaparib 100 mg
n=27 Participants
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 Participants
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Platelets
|
0 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Glucose (increase)
|
2 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Glucose (decrease)
|
3 Participants
|
3 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Amylase
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Hemoglobin
|
2 Participants
|
3 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
White blood cells
|
5 Participants
|
11 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Absolute neutrophil count
|
3 Participants
|
6 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Lymphocytes
|
3 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Activated partial thromboplastin time
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Alanine aminotransferase
|
2 Participants
|
3 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Aspartate aminotransferase
|
3 Participants
|
1 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Alkaline phosphatase
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Gamma glutamyl transferase
|
4 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Albumin
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Total bilirubin
|
0 Participants
|
4 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Sodium (decrease)
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Potassium (increase)
|
0 Participants
|
1 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Creatinine
|
0 Participants
|
2 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Calcium (decrease)
|
3 Participants
|
3 Participants
|
|
Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
Lipase
|
2 Participants
|
0 Participants
|
Adverse Events
Olaparib 100 mg
Serious events: 5 serious events
Other events: 27 other events
Deaths: 3 deaths
Olaparib 400 mg
Serious events: 9 serious events
Other events: 26 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Olaparib 100 mg
n=27 participants at risk
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 participants at risk
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Convulsion
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Olaparib 100 mg
n=27 participants at risk
Participants received two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
Olaparib 400 mg
n=27 participants at risk
Participants received eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion was met.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
18.5%
5/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
55.6%
15/27 • Number of events 19 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
51.9%
14/27 • Number of events 17 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
6/27 • Number of events 8 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
37.0%
10/27 • Number of events 16 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
29.6%
8/27 • Number of events 8 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
22.2%
6/27 • Number of events 6 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
4/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
29.6%
8/27 • Number of events 10 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
18.5%
5/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
18.5%
5/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
63.0%
17/27 • Number of events 19 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
70.4%
19/27 • Number of events 25 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
14.8%
4/27 • Number of events 4 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
22.2%
6/27 • Number of events 6 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.8%
4/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 4 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.5%
5/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.2%
6/27 • Number of events 7 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
14.8%
4/27 • Number of events 4 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.9%
7/27 • Number of events 7 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
6/27 • Number of events 6 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.7%
1/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
14.8%
4/27 • Number of events 4 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
22.2%
6/27 • Number of events 9 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
37.0%
10/27 • Number of events 23 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
11.1%
3/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
25.9%
7/27 • Number of events 7 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
11.1%
3/27 • Number of events 3 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.6%
8/27 • Number of events 8 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
14.8%
4/27 • Number of events 5 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
9/27 • Number of events 9 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
7.4%
2/27 • Number of events 2 • Day 1 to 480 (maximum observed duration)
Safety population included all participants who received at least one dose of study drug.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: +1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER