NCT00628251

Brief Summary

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_2

Geographic Reach
9 countries

24 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

July 30, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2009

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

June 3, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
Last Updated

December 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

February 26, 2008

Results QC Date

January 14, 2015

Last Update Submit

November 12, 2019

Conditions

Ovarian Neoplasms

Keywords

Advanced ovarian cancerBRCA1 proteinBRCA2 proteinPoly(ADP ribose) polymerases

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

    Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

Secondary Outcomes (10)

  • Objective Response Rate (ORR)

    At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

  • Disease Control Rate

    At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

  • Overall Duration of Response

    At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

  • Best Percentage Change in Tumour Size

    At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

  • Best Percentage Change From Baseline in CA-125 Levels

    At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

  • +5 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

AZD2281 Oral 200 mg BID

Drug: AZD2281

2

ACTIVE COMPARATOR

Liposomal Doxorubicin

Drug: Liposomal Doxorubicin

3

EXPERIMENTAL

AZD2281 Oral 400 mg BID

Drug: AZD2281

Interventions

AZD2281DRUG

400mg Oral twice daily

Also known as: Olaparib
3
Liposomal DoxorubicinDRUG

50mg/m2 Monthly Intravenous

Also known as: Doxil®
2

Eligibility Criteria

Age18 Years - 130 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  • Progressive or recurrent disease after platinum-based chemotherapy
  • Measurable disease by RECIST

You may not qualify if:

  • Previous anthracycline treatment
  • Brain metastases
  • Less than 28 days since last treatment used to treat the disease
  • Considered a poor medical risk due to a serious uncontrolled disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

Los Angeles, California, 90048, United States

Location

Research Site

San Francisco, California, 94115, United States

Location

Research Site

Boca Raton, Florida, 33428, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

New York, New York, 10065, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

East Melbourne, 3002, Australia

Location

Research Site

Melbourne, Parkville, VIC 3050, Australia

Location

Research Site

Randwick, 2031, Australia

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Cologne, 50937, Germany

Location

Research Site

München, 81377, Germany

Location

Research Site

Haifa, 31096, Israel

Location

Research Site

Ramat Gan, 52621, Israel

Location

Research Site

Tel Aviv, 6423906, Israel

Location

Research Site

Szczecin, 70-111, Poland

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Hospitalet deLlobregat, 08907, Spain

Location

Research Site

Lund, 22185, Sweden

Location

Research Site

Cambridge, CB2 0QQ, United Kingdom

Location

Research Site

Edinburgh, EH4 2XR, United Kingdom

Location

Research Site

London, SE1 9RT, United Kingdom

Location

Research Site

Manchester, M20 4BX, United Kingdom

Location

Research Site

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (6)

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PMID: 37407274DERIVED

  • 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.

    PMID: 35170751DERIVED

  • Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.

    PMID: 32073956DERIVED

  • Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.

    PMID: 26961146DERIVED

  • Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.

    PMID: 23922302DERIVED

  • 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.

    PMID: 19238149DERIVED

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFanconi Anemia, Complementation Group D1

Interventions

olaparibliposomal doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Limitations and Caveats

The AEs reported include all events up to the OS data cut-off. After the PFS data cut-off, AEs were only collected for the olaparib and cross-over groups. The safety profile of these 2 groups at OS was consistent with that at the time of PFS.

Results Point of Contact

Title
Paula del Rosario
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com
+44 7884 735492

Study Officials

  • Jane Robertson, BSc, MBCHB, MD

    AstraZeneca

    STUDY DIRECTOR

  • Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

July 30, 2008

Primary Completion

September 15, 2009

Study Completion

September 19, 2018

Last Updated

December 5, 2019

Results First Posted

June 3, 2016

Record last verified: 2019-11

Locations

AU(3)IL(3)US(6)GB(5)ES(2)BE(1)DE(2)PL(1)SE(1)