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Active, not recruitingNCT01844986SOLO-1Updated Dec 10, 2025Results posted

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

A Phase 3 interventional study of Olaparib 300mg tablets in Newly Diagnosed, Advanced Ovarian Cancer and FIGO Stage III-IV, sponsored by AstraZeneca. Active, not recruiting at 177 sites in 15 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years to 130 Years
Sex
Female
01

Study summary

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Read the detailed description

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.

02

Conditions studied

  • Newly Diagnosed
  • Advanced Ovarian Cancer
  • FIGO Stage III-IV
  • BRCA Mutation
  • Complete Response
  • Partial Response
  • First Line Platinum Chemotherapy

Keywords

  • BRCA
  • Ovarian Cancer
  • Chemotherapy
  • PARP inhibitor
  • First Line
  • FIGO Stage III
  • FIGO Stage IV
03

In context

Pathologic Complete Response

138 studies on the registry are indexed under Pathologic Complete Response; 57 are open to participants now.

This study's enrollment of 450 is above the median of 85 across 92 interventional studies indexed under Pathologic Complete Response.

Browse Pathologic Complete Response studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female patients with newly diagnosed, confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed platinum based chemotherapy (intravenous or intraperitoneal).
  • Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a and/or upfront or interval debulking surgery.
  • Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
  • Patients who have completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation:
  • Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study.
  • Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion criteria

Exclusion Criteria:

  • BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc).
  • Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)
  • Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's chemotherapy treatment.
  • Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible).
  • Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
  • Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or disease).
  • Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage \<2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Olaparib tablets p.o. 300mg twice daily

    Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

    Drug: Olaparib 300mg tablets

  • Placebo comparator
    Placebo tablets p.o. twice daily

    Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

    Drug: Olaparib 300mg tablets

Interventions

  • DrugOlaparib 300mg tablets

    Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

    To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

    Time frame: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

Secondary outcomes

  1. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.

    Time frame: Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

  2. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death

    Time frame: CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018

  3. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second progression (PFS2)

    Time frame: Following first progression disease then assessed per local practice every 12 weeks until second progression.

  4. Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

    To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

    Time frame: Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported

  5. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

    Time frame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

  6. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

    Time frame: Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

  7. Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)

    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

    Time frame: Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.

  8. Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS

    To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)

    Time frame: Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.

07

Results

Posted Jul 9, 2019
Limitations and caveats
The data presented based on the March DCO (17 May 2018) are not the final analyses for OS, TFST, TSST, and TDT. Further analyses of these (numbered as endpoints 2, 6, 7 and 8 in Outcome Measures section) will be performed as planned in the protocol and SAP when the pre-specified number of OS events are achieved.

Participant flow

Global Cohort: 391 randomised. First/Last patient randomised 03Sep2013/06Mar2015. China Cohort: 64 randomised. First/Last patient randomised 09Jan2015/22Mar2016. A total of 450 patients randomised (386 global cohort only, 64 China cohort (of which 5 included in global cohort)). Global Cohort used for hypotheses testing of study.

Overall Study (Global Cohort)
Participant flow — Overall Study (Global Cohort)
MilestoneOlaparib 300mg TabletsPlacebo Tablets
Started260131
Completed18391
Not completed7740
Withdrew: Severe non-compliance to protocol10
Withdrew: Withdrawal by subject2114
Withdrew: Death5526
Overall Study (China Cohort)
Participant flow — Overall Study (China Cohort)
MilestoneOlaparib 300mg TabletsPlacebo Tablets
Started4420
Completed3314
Not completed116
Withdrew: Withdrawal by subject10
Withdrew: Death106

Outcome measures

PrimaryProgression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

Time frame:
Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
Reported as:
Median · Months
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)NA (NA to NA)13.8 (11.1 to 18.2)NA (NA to NA)9.3 (6.4 to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.30 · 95% CI 0.23 to 0.41A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.46 · 95% CI 0.23 to 0.97A hazard ratio \< 1 favours olaparib
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS). Reports results of a pre-specified interim analysis; results for final OS analysis (235 OS events) anticipated 2029.

Time frame:
Assessed every 4 weeks until treatment discontinues (up to a max of 156 weeks), then as per protocol. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall SurvivalNA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = 0.8903 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.95 · 95% CI 0.60 to 1.53A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.77 · 95% CI 0.29 to 2.28A hazard ratio \< 1 favours olaparib
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen-125 (CA-125) or death

Time frame:
CA-125 performed at baseline + every 4 weeks. Radiologic scans performed at baseline + every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. DCO:17May2018
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or DeathNA (NA to NA)12.0 (10.8 to 16.6)NA (NA to NA)8.9 (6.4 to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.30 · 95% CI 0.23 to 0.40A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.47 · 95% CI 0.23 to 0.99A hazard ratio \<1 favours Olaparib.
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second progression (PFS2)

Time frame:
Following first progression disease then assessed per local practice every 12 weeks until second progression.
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second ProgressionNA (NA to NA)41.9 (36.5 to 47.9)NA (NA to NA)NA (NA to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = 0.0002 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.50 · 95% CI 0.35 to 0.72A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.55 · 95% CI 0.23 to 1.35A hazard ratio \<1 favours Olaparib.
SecondaryChange From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

Time frame:
Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported
Reported as:
Least squares mean · Scores on a scale
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
Scores on a scaleOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)0.30 (-0.717 to 1.318)3.30 (1.839 to 4.758)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Mixed Models Analysis · p = 0.0010 · Mean difference (final values): -3.00 · 95% CI -4.779 to -1.216Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time frame:
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)51.8 (44.3 to NA)15.1 (12.7 to 20.5)34.3 (23.1 to NA)10.3 (6.9 to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.30 · 95% CI 0.22 to 0.40A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.58 · 95% CI 0.29 to 1.23A hazard ratio \<1 favours Olaparib.
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time frame:
Assessed every 12 weeks following treatment discontinuation. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)NA (NA to NA)40.7 (32.9 to 47.7)NA (NA to NA)27.4 (19.4 to NA)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.45 · 95% CI 0.32 to 0.63A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.55 · 95% CI 0.25 to 1.26A hazard ratio \<1 favours Olaparib.
SecondaryEfficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)

To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT). Reports results of a pre-specified interim analysis; final analysis results will later be added at time of final OS analysis (anticipated 2029).

Time frame:
Time elapsed from randomization to study treatment discontinuation or death. Analysis performed with DCO: 17May2018. Further analyses will be performed at 7 years (descriptive), after 206 events and after 60% maturity.
Reported as:
Median · Months
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)24.6 (24.0 to 24.8)13.8 (11.2 to 16.4)24.8 (14.2 to 24.9)8.6 (5.9 to 24.8)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.63 · 95% CI 0.51 to 0.79A hazard ratio \< 1 favours olaparib
  • Olaparib 300mg Tablets (China Cohort) vs Placebo Tablets (China Cohort) · Regression, Cox · Hazard ratio (hr): 0.81 · 95% CI 0.47 to 1.42A hazard ratio \<1 favours Olaparib.
SecondaryEfficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS

To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)

Time frame:
Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.
Reported as:
Median · Months
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS
MonthsOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFSNA (NA to NA)13.8 (11.1 to 18.2)
Statistical analysis
  • Olaparib 300mg Tablets (Global Cohort) vs Placebo Tablets (Global Cohort) · Regression, Cox · p = <0.0001 (Determined using a log-rank test stratified by response to previous platinum chemotherapy) · Hazard ratio (hr): 0.30 · 95% CI 0.22 to 0.40A hazard ratio \< 1 favours olaparib

Adverse events

Collected over All adverse events (AEs) were collected from informed consent through treatment and safety follow-up period (30 days after study drug discontinued). Global cohort subjects were treated for an average of 1.7 years in Olaparib arm and 1.3 years in placebo arm. Subjects were followed up for all-cause mortality to end of study (no pre-specified max time). Global cohort subjects without a death reported were followed up for an average of 43.5 months in Olaparib arm and 42.5 months in placebo arm.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Olaparib 300mg Tablets (Global Cohort)55/260 (21.2%)54/260 (20.8%)253/260 (97.3%)
Placebo Tablets (Global Cohort)27/131 (20.6%)16/130 (12.3%)117/130 (90%)
Olaparib 300mg Tablets (China Cohort)10/44 (22.7%)13/44 (29.5%)43/44 (97.7%)
Placebo Tablets (China Cohort)6/20 (30%)3/20 (15%)18/20 (90%)
Most frequent serious events
Showing 10 of 68
Most frequent serious events
EventOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
AnaemiaBlood and lymphatic system disorders17/2600/1308/440/20
InfectionInfections and infestations0/2600/1300/441/20
Lumbar vertebral fractureInjury, poisoning and procedural complications0/2600/1300/441/20
Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders0/2600/1300/441/20
NeutropeniaBlood and lymphatic system disorders2/2600/1302/440/20
Breast cancer femaleNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2603/1300/440/20
Bone marrow failureBlood and lymphatic system disorders0/2600/1301/440/20
LeukopeniaBlood and lymphatic system disorders1/2600/1301/440/20
ThrombocytopeniaBlood and lymphatic system disorders0/2600/1301/440/20
GastroenteritisInfections and infestations0/2600/1301/440/20
Most frequent other events
Showing 10 of 63
Most frequent other events
EventOlaparib 300mg Tablets (Global Cohort)Placebo Tablets (Global Cohort)Olaparib 300mg Tablets (China Cohort)Placebo Tablets (China Cohort)
NauseaGastrointestinal disorders201/26049/13028/445/20
AnaemiaBlood and lymphatic system disorders90/26012/13021/443/20
VomitingGastrointestinal disorders104/26019/13018/443/20
FatigueGeneral disorders106/26039/13016/443/20
Upper respiratory tract infectionInfections and infestations28/26012/13017/446/20
NeutropeniaBlood and lymphatic system disorders40/2609/13017/441/20
Decreased appetiteMetabolism and nutrition disorders51/26013/13017/441/20
DiarrhoeaGastrointestinal disorders89/26032/1308/444/20
LeukopeniaBlood and lymphatic system disorders16/2605/13015/442/20
DizzinessNervous system disorders51/26020/1308/446/20

Baseline characteristics

Global Cohort (391 subjects): 260 Olaparib 131 Placebo China Cohort (64 subjects): 44 Olaparib 20 Placebo Included in both cohorts (5 subjects): 4 Olaparib 1 Placebo Total (450 subjects): 300 Olaparib 150 Placebo

Age, Continuous
Age, Continuous(Years)Olaparib 300mg Tablets (Global Cohort & China Cohort)Placebo Tablets (Global Cohort & China Cohort)Total
Global Cohort53.6 ± 9.3853.4 ± 9.7953.5 ± 9.51
China Cohort50.7 ± 7.2751.5 ± 7.9551.0 ± 7.44
Sex: Female, Male
Sex: Female, Male(Participants)Olaparib 300mg Tablets (Global Cohort & China Cohort)Placebo Tablets (Global Cohort & China Cohort)Total
Global Cohort — Female260131391
Global Cohort — Male000
China Cohort — Female442064
China Cohort — Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Olaparib 300mg Tablets (Global Cohort & China Cohort)Placebo Tablets (Global Cohort & China Cohort)Total
Global Cohort — American Indian or Alaska Native011
Global Cohort — Asian392059
Global Cohort — Native Hawaiian or Other Pacific Islander112
Global Cohort — Black or African American224
Global Cohort — White214106320
Global Cohort — More than one race101
Global Cohort — Unknown or Not Reported314
China Cohort — American Indian or Alaska Native000
China Cohort — Asian442064
China Cohort — Native Hawaiian or Other Pacific Islander000
China Cohort — Black or African American000
China Cohort — White000
China Cohort — More than one race000
China Cohort — Unknown or Not Reported000
Response to previous platinum chemotherapy (as randomised)
Response to previous platinum chemotherapy (as randomised)(Participants)Olaparib 300mg Tablets (Global Cohort & China Cohort)Placebo Tablets (Global Cohort & China Cohort)Total
Global Cohort — Complete Response213107320
Global Cohort — Partial Response472471
China Cohort — Complete Response371855
China Cohort — Partial Response729
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Study locations

177 sites

Showing the first 100 of 177 sites across 15 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5. PubMed 39695768 ↗
  • DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549. Epub 2022 Sep 9. PubMed 36082969 ↗
  • Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4. PubMed 35170751 ↗
  • Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26. PubMed 34715071 ↗
  • Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13. PubMed 33862001 ↗
  • Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21. PubMed 30345884 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2013 to primary completion in May 2018, 56 months.

Results were first posted in Jul 2019, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2013
First posted
May 3, 2013
StartActual
Aug 26, 2013
Primary completionActual
May 17, 2018
CompletionEst.
Aug 29, 2028
Results first posted
Jul 9, 2019
Last update
Dec 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01844986
Lead sponsor
AstraZeneca
Collaborators
GOG Foundation, Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 3, 2013
Start date
Aug 26, 2013
Primary completion
May 17, 2018
Completion
Aug 29, 2028 (estimated)
Results posted
Jul 9, 2019
Last update
Dec 10, 2025

Study contacts

Prof Paul DiSilvestro, MD
principal investigator · Women & Infants Hospital, Providence, Rhode Island, USA
Prof Kathleen Moore, MD
principal investigator · University of Oklahoma Health Sciences Center, Oklahoma City, USA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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