Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
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
2 other identifiers
interventional
265
15 countries
102
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Aug 2008
Longer than P75 for phase_2 ovarian-cancer
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2008
CompletedFirst Submitted
Initial submission to the registry
September 12, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2010
CompletedResults Posted
Study results publicly available
March 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2023
CompletedFebruary 3, 2025
January 1, 2025
1.8 years
September 12, 2008
December 7, 2012
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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. \[Full analysis set (FAS)\]
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)
Follow up every 12 weeks post progression, assessed maximum up to 90 months.
Objective Response Rate (ORR) (According to RECIST)
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
Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).
Duration of Response
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
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.
- +10 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALAZD2281
2
PLACEBO COMPARATORmatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (107)
Research Site
Berkeley, California, 94704, United States
Research Site
San Francisco, California, 94115, United States
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West Hollywood, California, 90048, United States
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Sunrise, Florida, 33027, United States
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West Palm Beach, Florida, 33401, United States
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Indianapolis, Indiana, 46202, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, 02215, United States
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New York, New York, 10016, United States
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Providence, Rhode Island, 02905, United States
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Adelaide, 5000, Australia
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East Bentleigh, 3165, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3000, Australia
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Nambour, 4560, Australia
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Randwick, 2031, Australia
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South Brisbane, 4101, Australia
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Toorak Gardens, 5065, Australia
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Wein, 1130, Austria
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Brussels, 1090, Belgium
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Leuven, 3000, Belgium
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Vancouver, British Columbia, V5Z 4E6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Québec, Quebec, G1R 2J6, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Olomouc, 775 20, Czechia
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Prague, 100 34, Czechia
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Tallinn, 11619, Estonia
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Tartu, 51014, Estonia
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Bordeaux, 33076, France
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Caen, 14076, France
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Lyon, 69373, France
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Nantes, 44202, France
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Paris, 75004, France
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Paris, 75020, France
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Reims, 51056, France
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Bonn, 53105, Germany
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Düsseldorf, 40217, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Hanover, 30177, Germany
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Kiel, 24105, Germany
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Marburg, 35043, Germany
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München, 81675, Germany
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Rostock, 18059, Germany
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Ulm, 89081, Germany
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Wiesbaden, 65199, Germany
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Haifa, 31096, Israel
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Holon, 58100, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Nahariya, 22100, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 64239, Israel
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Ẕerifin, 70300, Israel
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Amsterdam, 1066 CX, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Bialystok, 15-027, Poland
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Grzepnica, 72-003, Poland
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Lublin, 20 - 081, Poland
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Poznan, 60-569, Poland
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Poznan, 61-866, Poland
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Poznan, Poland
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Szczecin, 70-111, Poland
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Warsaw, 02-781, Poland
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Baia Mare, 430222, Romania
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Cluj-Napoca, 400015, Romania
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Iași, 700106, Romania
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Suceava, 720237, Romania
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Barnaul, 656049, Russia
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Obninsk, 249036, Russia
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Orenburg, 460021, Russia
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Perm, 614066, Russia
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Pyatigorsk, 357502, Russia
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Saint Petersburg, 197002, Russia
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Saint Petersburg, 197758, Russia
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Voronezh, 394000, Russia
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Yekaterinburg, 620036, Russia
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Córdoba, 14004, Spain
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Madrid, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28041, Spain
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Valencia, 46010, Spain
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Donetsk, 83092, Ukraine
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Kharkiv Region, 61024, Ukraine
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Kyiv, 03022, Ukraine
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Kyiv, 03115, Ukraine
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Lutsk, 43018, Ukraine
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Odesa, 65009, Ukraine
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Odesa, 65055, Ukraine
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Ternopil, 46023, Ukraine
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Uzhhorod, 88014, Ukraine
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Dundee, DD1 9SY, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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London, NW1 2PG, United Kingdom
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London, SW17 0QT, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
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Northwood, HA6 2RN, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Related Publications (8)
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.
PMID: 39695768DERIVEDTattersall 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.
PMID: 35170751DERIVEDLedermann 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.
PMID: 27824811DERIVEDLedermann 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.
PMID: 27617661DERIVEDMatulonis 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.
PMID: 27062051DERIVEDLedermann 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.
PMID: 24882434DERIVEDLedermann 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.
PMID: 22452356DERIVEDYap 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.
PMID: 19238149DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Mika Sovak, BSc, MBCHB, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Prof Jonathan A Lederman
University College, London
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 12, 2008
First Posted
September 16, 2008
Study Start
August 28, 2008
Primary Completion
June 30, 2010
Study Completion
October 12, 2023
Last Updated
February 3, 2025
Results First Posted
March 11, 2013
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
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.