Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
CompletedPhase 3Results postedLast updated 26 July 2022
What this trial tests
Phase 3 trial testing OLAPARIB in Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity in 266 participants. Completed in 19 July 2022.
Adults 18 to 130, female only, with Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity. 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.
Objective Response Rate (ORR)Primary· RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
To determine the efficacy of olaparib vs. physician's choice single agent chemotherapy by assessment of Objective Response Rate (ORR) using blinded independent central review (BICR)
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used by a Blinded Independent Central Review (BICR) to assess participant response to treatment
ORR is the number of participants with Complete Response (CR) or Partial Response (PR) in the Measurable Disease Analysis Set (MDAS). Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disea
Group
Value
95% CI
Olaparib 300 mg BID
109
Single Agent Chemotherapy
37
Progression Free Survival (PFS)Secondary· RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by progression free survival (PFS) using BICR assessment according to RECIST 1.1 criteria
PFS is defined as the time from randomization until the date of objective radiological disease progression according to RECIST 1.1 or death (by any cause in the absence of disease progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to disease progression (i.e., date of RECIST progression/death or censoring - date of randomization
Group
Value
95% CI
Olaparib 300 mg BID
13.4
10.9 – 14.1
Single Agent Chemotherapy
9.2
7.6 – 11.2
Time From Randomisation to Second Progression (PFS2)Secondary· Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by second progression (PFS2).
Time from randomization to PFS2 is defined as the time from the date of randomization to the earliest of the progression events subsequent to first progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could involve objective radiological, clinical, cancer antigen-125 (CA-125) progression or death. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG)
Group
Value
95% CI
Olaparib 300 mg BID
23.6
19.2 – 26.0
Single Agent Chemotherapy
19.6
16.9 – 21.8
Overall Survival (OS)Secondary· Visits to occur every 12 weeks from the date of first progression, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by overall survival (OS).
Overall survival is defined as the time from the date of randomisation until death due to any cause.
Group
Value
95% CI
Olaparib 300 mg BID
34.9
30.0 – 39.2
Single Agent Chemotherapy
32.9
23.5 – 43.2
Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or DeathSecondary· RECIST and CA-125 follow-up assessments performed every 8 weeks (±1week), up to 48 weeks, then every 12 weeks (±1week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to earliest progression by RECIST 1.1 or CA-125 or death.
Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG).
Group
Value
95% CI
Olaparib 300 mg BID
11.1
9.7 – 13.8
Single Agent Chemotherapy
7.9
6.9 – 9.4
Time From Randomization To First Subsequent Therapy Or Death (TFST)Secondary· Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to first subsequent therapy or death (TFST)
TFST is defined as the time from the date of randomisation to the earlier of first subsequent chemotherapy start date or death.
Anti-cancer treatments include chemotherapy and targeted agents.
Group
Value
95% CI
Olaparib 300 mg BID
15.4
13.5 – 17.6
Single Agent Chemotherapy
10.9
9.2 – 14.2
Time From Randomization To Second Subsequent Therapy Or Death (TSST)Secondary· Anti-cancer treatments initiated post discontinuation of study treatment and investigator's opinion of response and date of progression recorded, assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time from randomisation to second subsequent therapy or death (TSST)
TSST was defined as the time from the date of randomisation to the earlier of second subsequent chemotherapy start date or death.
Anti-cancer treatments include chemotherapy and targeted agents.
Group
Value
95% CI
Olaparib 300 mg BID
25.2
21.3 – 27.8
Single Agent Chemotherapy
19.9
18.0 – 24.2
Time From Randomization To Study Treatment Discontinuation Or Death (TDT)Secondary· Patients randomised to Olaparib administer their tablets orally at a dose of 300 mg twice daily and continue Olaparib until objective disease progression. Assessed from date of first patient randomised to data cut off: 16Apr2021 (approx. 6 years 2 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to study treatment discontinuation or death (TDT)
TDT was defined as the time from randomization to the earlier of the date of study treatment discontinuation or death.
Group
Value
95% CI
Olaparib 300 mg BID
13.1
10.2 – 14.6
Single Agent Chemotherapy
5.1
4.7 – 6.5
Duration of Response (DoR)Secondary· RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by duration of response (DoR) by BICR using RECIST 1.1 criteria for evaluable patients.
Duration of response is the time from the first documentation of complete response (CR) or partial response (PR) until the date of progression or death, or the last evaluable RECIST assessment for participants that do not progress or progress after 2 missed assessments. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment.
Group
Value
95% CI
Olaparib 300 mg BID
9.4
5.6 – 25.7
Single Agent Chemotherapy
10.2
5.5 – 15.3
Time to Response (TTR)Secondary· RECIST follow-up assessments performed every 8 weeks (±1 week), up to 48 weeks, then every 12 weeks (±1 week) from randomisation, assessed from date of first patient randomised to data cut off: 10Oct2018 (approx. 3 years 8 months)
To determine the efficacy of single agent olaparib vs. physician's choice single agent chemotherapy by time to response (TTR) by BICR using RECIST 1.1 criteria for evaluable patients.
TTR was defined as the time from randomization until the date of first documented response by Blinded independent central review (BICR) assessment.
Group
Value
95% CI
Olaparib 300 mg BID
2.0
1.8 – 3.9
Single Agent Chemotherapy
3.5
1.8 – 3.7
Mean Change From Baseline In Trial Outcome Index (TOI) ScoreSecondary· Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018
To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher HRQoL. A negative change in
Group
Value
95% CI
Olaparib 300 mg BID
-2.4
± 11.1
Selected Chemotherapy
-3.6
± 9.8
Number of Participants Who Show an Improvement in TOI ScoreSecondary· Baseline (Day 1) to Week 48 (±1 week). DCO: 10Oct2018
To compare the efficacy of single agent olaparib versus physician's choice single agent chemotherapy on the Health-related Quality of Life (HRQoL) as measured by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher health-related quality of li
Group
Value
95% CI
Olaparib 300 mg BID
25
Single Agent Chemotherapy
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Includes all AEs that had a start date or a worsening (increase in CTCAE grade) after the start of treatment up until the end of the 30 day follow-up period. The 30 day follow-up period will be defined as 30 days following discontinuation of olaparib/chemotherapy treatment. Assessed from randomisation to data cut off. DCO: 16Apr2021.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Olaparib 300 mg bd
Serious: 46/178 (26%)
Deaths: 116/178
Single Agent Chemotherapy
Serious: 14/76 (18%)
Deaths: 46/88
Serious adverse events (55 terms)
Reaction
System
Olaparib 300 mg bd
Single Agent Chemotherapy
Anaemia
Blood and lymphatic system disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Deep vein thrombosis
Vascular disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Gastroenteritis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Ileus
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Pneumonia
Infections and infestations
—
—
Syncope
Nervous system disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Urinary tract infection
Infections and infestations
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02983799 — Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
· Phase 2
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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: 26 July 2022
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/NCT02282020.