Adults 18 to 130, any sex, with Ovarian or Breast. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Tumour Response RatePrimary· Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Group
Value
95% CI
Breast Cancer
12.9
5.74 – 23.85
Ovarian Cancer
31.1
24.64 – 38.13
Pancreatic Cancer
21.7
7.46 – 43.7
Prostate Cancer
50
15.7 – 84.3
Other Cancers
8.3
0.21 – 38.48
All Patients
26.2
21.27 – 31.55
Objective Response RateSecondary· Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
Group
Value
95% CI
Breast Cancer
13.8
6.15 – 25.38
Ovarian Cancer
35.9
28.66 – 43.7
Pancreatic Cancer
21.7
7.46 – 43.7
Prostate Cancer
57.1
18.41 – 90.1
Other Cancers
9.1
0.23 – 41.28
All Patients
29.3
23.92 – 35.19
Progression Free SurvivalSecondary· Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months
Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
Group
Value
95% CI
Breast Cancer
3.68
1.76 – 7.52
Ovarian Cancer
7.03
3.65 – 11.24
Pancreatic Cancer
4.55
1.81 – 8.21
Prostate Cancer
7.15
2.63 – 17.45
Overall SurvivalSecondary· Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.
Group
Value
95% CI
Breast Cancer
11.01
5.68 – 24.18
Ovarian Cancer
16.62
9.43 – NA
Pancreatic Cancer
9.81
3.84 – 16.62
Prostate Cancer
18.38
6.24 – 25.46
Overall Survival Rate at 12 MonthsSecondary· Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months
Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose
Group
Value
95% CI
Breast Cancer
44.7
5.68 – 24.18
Ovarian Cancer
64.4
9.43 – NA
Pancreatic Cancer
40.9
3.84 – 16.62
Prostate Cancer
50
6.24 – 25.46
Duration of ResponseSecondary· From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months
Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.
Group
Value
95% CI
Breast Cancer
204
149.5 – 405
Ovarian Cancer
225
143 – 410
Pancreatic Cancer
134
131 – 141
Prostate Cancer
326.5
164 – 476
Other Cancers
165
165 – 165
All Patients
208
134 – 410
Disease Control Rate at Week 16Secondary· Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16
Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.
Group
Value
95% CI
Breast Cancer
37.1
25.16 – 50.31
Ovarian Cancer
58
50.73 – 65.08
Pancreatic Cancer
47.8
26.82 – 69.41
Prostate Cancer
62.5
24.49 – 91.48
Other Cancers
33.3
9.92 – 65.11
All Patients
52
46.18 – 57.81
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05457257 — Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Pr
· Phase 4
· completed
NCT05158062 — Pembrolizumab and Bevacizumab With Chemotherapy Followed by Pembrolizumab, Bevacizumab and Olaparib in Recurrent Ovarian
· Phase 2
· unknown
NCT05171816 — Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (Ch
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01078662.