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

January 30, 2025 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Research Site
      • East Bentleigh, Australia, 3165
        • Research Site
      • Heidelberg, Australia, 3084
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Nambour, Australia, 4560
        • Research Site
      • Randwick, Australia, 2031
        • Research Site
      • South Brisbane, Australia, 4101
        • Research Site
      • Toorak Gardens, Australia, 5065
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Wein, Austria, 1130
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Canada
      • Quebec, Canada, G1R 2J6
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Brno, Czechia, 625 00
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 10, Czechia, 100 34
        • Research Site
  • Estonia
      • Tallinn, Estonia, 11619
        • Research Site
      • Tartu, Estonia, 51014
        • Research Site
  • France
      • Bordeaux, France, 33076
        • Research Site
      • Caen Cedex, France, 14076
        • Research Site
      • Lyon Cedex 08, France, 69373
        • Research Site
      • Nantes, France, 44202
        • Research Site
      • Paris, France, 75020
        • Research Site
      • Paris, France, 75004
        • Research Site
      • Reims Cedex, France, 51056
        • Research Site
  • Germany
      • Bonn, Germany, 53105
        • Research Site
      • Düsseldorf, Germany, 40217
        • Research Site
      • Essen, Germany, 45147
        • Research Site
      • Freiburg, Germany, 79106
        • Research Site
      • Göttingen, Germany, 37075
        • Research Site
      • Hannover, Germany, 30177
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Marburg, Germany, 35043
        • Research Site
      • München, Germany, 81675
        • Research Site
      • Rostock, Germany, 18059
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
      • Wiesbaden, Germany, 65199
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Holon, Israel, 58100
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Nahariya, Israel, 22100
        • Research Site
      • Ramat Gan, Israel, 52621
        • Research Site
      • Tel-Aviv, Israel, 64239
        • Research Site
      • Zerifin, Israel, 70300
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
  • Poland
      • Białystok, Poland, 15-027
        • Research Site
      • Grzepnica, Poland, 72-003
        • Research Site
      • Lublin, Poland, 20 - 081
        • Research Site
      • Poznan, Poland, 60-569
        • Research Site
      • Poznan, Poland, 61-866
        • Research Site
      • Poznań, Poland
        • Research Site
      • Szczecin, Poland, 70-111
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
  • Romania
      • Baia Mare, Romania, 430222
        • Research Site
      • Cluj-Napoca, Romania, 400015
        • Research Site
      • Iasi, Romania, 700106
        • Research Site
      • Suceava, Romania, 720237
        • Research Site
  • Russian Federation
      • Barnaul, Russian Federation, 656049
        • Research Site
      • Ekaterinburg, Russian Federation, 620036
        • Research Site
      • Obninsk, Russian Federation, 249036
        • Research Site
      • Orenburg, Russian Federation, 460021
        • Research Site
      • Perm, Russian Federation, 614066
        • Research Site
      • Pyatigorsk, Russian Federation, 357502
        • Research Site
      • Saint-Petersburg, Russian Federation, 197758
        • Research Site
      • St. Petersburg, Russian Federation, 197002
        • Research Site
      • Voronezh, Russian Federation, 394000
        • Research Site
  • Spain
      • Córdoba, Spain, 14004
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 08035
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
  • Ukraine
      • Donetsk, Ukraine, 83092
        • Research Site
      • Kharkiv Region, Ukraine, 61024
        • Research Site
      • Kyiv, Ukraine, 03115
        • Research Site
      • Kyiv, Ukraine, 03022
        • Research Site
      • Lutsk, Ukraine, 43018
        • Research Site
      • Odesa, Ukraine, 65009
        • Research Site
      • Odesa, Ukraine, 65055
        • Research Site
      • Ternopil, Ukraine, 46023
        • Research Site
      • Uzhhorod, Ukraine, 88014
        • Research Site
  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Edinburgh, United Kingdom, EH4 2XR
        • Research Site
      • London, United Kingdom, NW1 2PG
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Research Site
      • London, United Kingdom, SW17 0QT
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Northwood, United Kingdom, HA6 2RN
        • Research Site
      • Sutton, United Kingdom, SM2 5PT
        • Research Site
      • Wirral, United Kingdom, CH63 4JY
        • Research Site
  • United States
    • California
      • Berkeley, California, United States, 94704
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
      • West Hollywood, California, United States, 90048
        • Research Site
    • Florida
      • Sunrise, Florida, United States, 33027
        • Research Site
      • West Palm Beach, Florida, United States, 33401
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
matching placebo
Drug: matching placebo
matching placebo bid
Experimental: 1
AZD2281
Drug: AZD2281
Tablets Oral BID
Other Names:
  • Olaparib, Lynparza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Follow up every 12 weeks post progression, assessed maximum up to 90 months.
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.
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.
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
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).
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]
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.
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.
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.
Percentage change from baseline to Week 24 in target tumour size.
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 percentage change from baseline in CA-125 level
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.
Best overall response from radiologic assessments. [FAS]
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.
RECIST and CA-125 response separately and combined [Patients evaluable for either CA-125 response or RECIST response]
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.
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]
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.
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]
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.
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]
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.
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]
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.
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FOSI set]
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.
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for TOI set]
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.
The time to worsening was compared between treatments for each of the TOI, FOSI and total FACT-O. [Evaluable for FACT-O set]
Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Mika Sovak, BSc, MBCHB, MD, AstraZeneca
  • Principal Investigator: Prof Jonathan A Lederman, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2008

Primary Completion (Actual)

June 30, 2010

Study Completion (Actual)

October 12, 2023

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

September 15, 2008

First Posted (Estimated)

September 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0810C00019
  • 2008-003439-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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