Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer

A Phase 2 study testing AZD2281 in people with Ovarian Cancer, run by AstraZeneca at 107 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy Read more about this study

Who is it for?: Ages 18 to 130 years, women only
Conditions the study is for: Ovarian Cancer
What is being tested?: AZD2281
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 265 participants
Where: 107 sitesin 17 countries
Study dates: 28 Aug 2008to 12 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.

Who cannot join

Previous treatment with PARP inhibitors including AZD2281
Patients with low grade ovarian carcinoma.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).

Trial locations and contacts

107 sites in 17 countries.

Country

City, postcode or hospital

107 sites in 17 countries

Germany12 sites

Research Site
Bonn, 53105
Research Site
Düsseldorf, 40217
Research Site
Essen, 45147
Research Site
Freiburg im Breisgau, 79106
Research Site
Göttingen, 37075
Research Site
Hanover, 30177
Research Site
Kiel, 24105
Research Site
Marburg, 35043
Research Site
München, 81675
Research Site
Rostock, 18059
Research Site
Ulm, 89081
Research Site
Wiesbaden, 65199

Other trials in Germany

United States11 sites

Research Site
Berkeley, California, 94704
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Boston, Massachusetts, 02215
Research Site
Indianapolis, Indiana, 46202
Research Site
New York, New York, 10016
Research Site
Providence, Rhode Island, 02905
Research Site
San Francisco, California, 94115
Research Site
Sunrise, Florida, 33027
Research Site
West Hollywood, California, 90048
Research Site
West Palm Beach, Florida, 33401

Other trials in United States

Russia9 sites

Research Site
Barnaul, 656049
Research Site
Obninsk, 249036
Research Site
Orenburg, 460021
Research Site
Perm, 614066
Research Site
Pyatigorsk, 357502
Research Site
Saint Petersburg, 197002
Research Site
Saint Petersburg, 197758
Research Site
Voronezh, 394000
Research Site
Yekaterinburg, 620036

Other trials in Russia

Ukraine9 sites

Research Site
Donetsk, 83092
Research Site
Kharkiv Region, 61024
Research Site
Kyiv, 03022
Research Site
Kyiv, 03115
Research Site
Lutsk, 43018
Research Site
Odesa, 65009
Research Site
Odesa, 65055
Research Site
Ternopil, 46023
Research Site
Uzhhorod, 88014

Other trials in Ukraine

United Kingdom9 sites

Research Site
Dundee, DD1 9SY
Research Site
Edinburgh, EH4 2XR
Research Site
London, NW1 2PG
Research Site
London, SW17 0QT
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Metropolitan Borough of Wirral, CH63 4JY
Research Site
Northwood, HA6 2RN
Research Site
Sutton, SM2 5PT

Other trials in United Kingdom

Australia8 sites

Research Site
Adelaide, 5000
Research Site
East Bentleigh, 3165
Research Site
Heidelberg, 3084
Research Site
Melbourne, 3000
Research Site
Nambour, 4560
Research Site
Randwick, 2031
Research Site
South Brisbane, 4101
Research Site
Toorak Gardens, 5065

Other trials in Australia

Israel8 sites

Research Site
Haifa, 31096
Research Site
Holon, 58100
Research Site
Jerusalem, 91031
Research Site
Jerusalem, 91120
Research Site
Nahariya, 22100
Research Site
Ramat Gan, 52621
Research Site
Tel Aviv, 64239
Research Site
Tsrifin, 70300

Other trials in Israel

Poland8 sites

Research Site
Bialystok, 15-027
Research Site
Grzepnica, 72-003
Research Site
Lublin, 20 - 081
Research Site
Poznan, 60-569
Research Site
Poznan, 61-866
Research Site
Poznan
Research Site
Szczecin, 70-111
Research Site
Warsaw, 02-781

Other trials in Poland

France7 sites

Research Site
Bordeaux, 33076
Research Site
Caen, 14076
Research Site
Lyon, 69373
Research Site
Nantes, 44202
Research Site
Paris, 75004
Research Site
Paris, 75020
Research Site
Reims, 51056

Other trials in France

Spain5 sites

Research Site
Córdoba, 14004
Research Site
Madrid, 08035
Research Site
Madrid, 28007
Research Site
Madrid, 28041
Research Site
Valencia, 46010

Other trials in Spain

Canada4 sites

Research Site
Québec, Quebec, G1R 2J6
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia4 sites

Research Site
Brno, 625 00
Research Site
Brno, 656 53
Research Site
Olomouc, 775 20
Research Site
Prague, 100 34

Other trials in Czechia

Romania4 sites

Research Site
Baia Mare, 430222
Research Site
Cluj-Napoca, 400015
Research Site
Iași, 700106
Research Site
Suceava, 720237

Other trials in Romania

Austria3 sites

Research Site
Innsbruck, 6020
Research Site
Vienna, 1090
Research Site
Wein, 1130

Other trials in Austria

Belgium2 sites

Research Site
Brussels, 1090
Research Site
Leuven, 3000

Other trials in Belgium

Estonia2 sites

Research Site
Tallinn, 11619
Research Site
Tartu, 51014

Other trials in Estonia

Netherlands2 sites

Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Official title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

Conditions: Ovarian Cancer
Being tested: AZD2281, matching placebo
Keywords: Serous,, Ovarian cancer,, PARP,, BRCA1,, BRCA2,, Poly(ADP ribose) polymerases,, Platinum sensitive,, Homologous Recombination Deficiency (HRD)
Medical subject headings: Ovarian Neoplasms, Fanconi Anemia, Complementation Group D1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2281Drug
Also called Olaparib, Lynparza
Tablets Oral BID
matching placeboDrug
matching placebo bid

Study groups in NCT00753545
Study group	Role	What they receive
1	Experimental	AZD2281 Receives: Drug: AZD2281
2	Placebo comparator	matching placebo Receives: Drug: matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.

Secondary outcomes (15)

Overall Survival (OS)
OS = time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date patient was known to be alive.
Measured: Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Objective Response Rate (ORR) (According to RECIST)
For each treatment group, the ORR was the number of Complete Response (CR) and Partial Response (PR) divided by the number of patients in the group in the FAS with measurable disease at baseline (displayed as a percentage below). Evaluable for response set
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Disease Control Rate
Disease control rate was defined as the percentage of patients who have at least 1 confirmed visit response of CR or PR or have demonstrated SD or NED for at least 23 weeks (ie, 24 weeks +/- 1 week) prior to any evidence of progression. [FAS]
Measured: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Duration of Response
Duration of response = time from assessment prior to timepoint where PR or CR confirmed (i.e. initial assessment of PR/CR), until earliest date of objective progression or death. [Responding patients only]. There were insufficient responses to enable conclusions to be drawn.
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Percentage Change From Baseline in Tumour Size at Week 24
Percentage change from baseline to Week 24 in target tumour size.
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Best percentage change from baseline in CA-125 level
Measured: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Best Objective Response
Best overall response from radiologic assessments. [FAS]
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.
RECIST and CA-125 Response Separately and Combined
RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Time to Earlier of CA-125 or RECIST Progression
Time from randomisation to the earlier date of radiological progression (per RECIST criteria) or CA-125 or death by any cause in the absence of objective progression. [FAS]
Measured: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Improvement Rate for FACT-O Symptom Index (FOSI)
The percentage of patients with an improvement in FOSI. Improvement was defined as a change from baseline of greater than or equal to +3. [Evaluable for FOSI set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Trial Outcome Index (TOI)
The percentage of patients with an improvement in TOI. Improvement was defined as a change from baseline of greater than or equal to +7. [Evaluable for TOI set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
The percentage of patients with an improvement in total FACT-O. Improvement was defined as a change from baseline of greater than or equal to +9. [Evaluable for FACT-O set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
FACT-O Symptom Index (FOSI) Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Trial Outcome Index(TOI)Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
Measured: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 200812 Oct 2023

First posted16 Sep 2008 (estimated)
Study start28 Aug 2008
Primary completion30 Jun 2010
Study completion12 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00753545
Sponsor's protocol ID: D0810C00019
Other IDs: 2008-003439-18, 2008
Status last verified: Jan 2025
First submitted: 12 Sep 2008
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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.
Expanded access: Available

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
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
Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.
PubMed 27824811
Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.
PubMed 27617661
Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.
PubMed 27062051
Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.
PubMed 24882434
Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.
PubMed 22452356
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
PubMed 19238149

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
ClinicalTrials.gov ID: NCT00753545
Acronym / sponsor ID: D0810C00019
Conditions: Ovarian Cancer
Keywords: Serous,, Ovarian cancer,, PARP,, BRCA1,, BRCA2,, Poly(ADP ribose) polymerases,, Platinum sensitive,, Homologous Recombination Deficiency (HRD)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 28 Aug 2008 (actual)
Primary completion: 30 Jun 2010 (actual)
Study completion: 12 Oct 2023 (actual)
First posted: 16 Sep 2008 (estimated)
Results: Posted 29 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD2281AZD2281
2	Placebo comparator	Drug: matching placebomatching placebo

Who may qualify

Ages: 18 to 130 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.

Key exclusion criteria (4 listed)

Previous treatment with PARP inhibitors including AZD2281
Patients with low grade ovarian carcinoma.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD2281Also: Olaparib, LynparzaTablets Oral BID	Drug	1
matching placebomatching placebo bid	Drug	2

Primary outcome

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. [Full analysis set (FAS)]

15 secondary outcomes

Overall Survival (OS)
Time frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Objective Response Rate (ORR) (According to RECIST)
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Disease Control Rate
Time frame: Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Duration of Response
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Percentage Change From Baseline in Tumour Size at Week 24
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
Best Percentage Change in Cancer Antigen 125 (CA-125) Levels
Time frame: CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.
Best Objective Response
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.
RECIST and CA-125 Response Separately and Combined
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Time to Earlier of CA-125 or RECIST Progression
Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.
Improvement Rate for FACT-O Symptom Index (FOSI)
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Trial Outcome Index (TOI)
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
FACT-O Symptom Index (FOSI) Time to Worsening
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Trial Outcome Index(TOI)Time to Worsening
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.
Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening
Time frame: Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Results and safety

Results posted to the registry on 29 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olaparib 400 mg bd	136	28
Placebo bd	129	11

Primary outcome: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])

Time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.. Median (95% Confidence Interval). Unit: Months

Measure	Olaparib 400 mg bd n = 136	Placebo bd n = 129
Value	8.4 (7.4 to 11.5)	4.8 (4.0 to 5.5)

Olaparib 400 mg bd vs Placebo bd: Hazard Ratio (HR): 0.35 (95% CI 0.25 to 0.49), p <0.00001, Regression, Cox

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Olaparib 400 mg bd	31 of 136 (22.8%)	129 of 136 (94.9%)	Not reported
Placebo	11 of 128 (8.6%)	111 of 128 (86.7%)	Not reported

Limitations and caveats (from the sponsor): For OM DoR: The subset of patients evaluable for response who responded to study treatment.Values in results table may be under-estimates as some patients had not progressed at final analysis,so true duration is likely to be greater than in database.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39695768Barnicle 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.
Derived from this study: PubMed 35170751Tattersall 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.
Derived from this study: PubMed 27824811Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.
Derived from this study: PubMed 27617661Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.
Derived from this study: PubMed 27062051Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.
Derived from this study: PubMed 24882434Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.
Derived from this study: PubMed 22452356Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.
Derived from this study: PubMed 19238149Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
CSR\_Synopsis\_RedactedLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mika Sovak, BSc, MBCHB, MD study director

AstraZeneca

Prof Jonathan A Lederman principal investigator

University College, London

107 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2281 in people with Ovarian Cancer, run by AstraZeneca at 107 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in Germany, United States, Russia, Ukraine, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (time frame: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00753545, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.