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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00628251
Registration number
NCT00628251
Ethics application status
Date submitted
26/02/2008
Date registered
5/03/2008
Date last updated
5/12/2019
Titles & IDs
Public title
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
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Scientific title
A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
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Secondary ID [1]
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D0810C00012
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Universal Trial Number (UTN)
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Trial acronym
ICEBERG 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - AZD2281
Treatment: Drugs - Liposomal Doxorubicin
Treatment: Drugs - AZD2281
Experimental: 1 - AZD2281 Oral 200 mg BID
Active Comparator: 2 - Liposomal Doxorubicin
Experimental: 3 - AZD2281 Oral 400 mg BID
Treatment: Drugs: AZD2281
400mg Oral twice daily
Treatment: Drugs: Liposomal Doxorubicin
50mg/m2 Monthly Intravenous
Treatment: Drugs: AZD2281
200mg oral twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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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)
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Timepoint [1]
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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)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
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Timepoint [1]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [2]
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Disease Control Rate
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Assessment method [2]
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The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients
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Timepoint [2]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [3]
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Overall Duration of Response
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Assessment method [3]
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The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)
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Timepoint [3]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [4]
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Best Percentage Change in Tumour Size
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Assessment method [4]
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The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication
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Timepoint [4]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [5]
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Best Percentage Change From Baseline in CA-125 Levels
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Assessment method [5]
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Best percentage change in cancer antigen 125 (CA-125) levels
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Timepoint [5]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [6]
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Confirmed RECIST Response and/or CA-125 Response
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Assessment method [6]
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The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.
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Timepoint [6]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals
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Timepoint [7]
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At the time of the cut-off for the final analysis of overall survival (30 April 2010)
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Secondary outcome [8]
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Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)
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Assessment method [8]
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Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.
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Timepoint [8]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [9]
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Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
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Assessment method [9]
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Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.
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Timepoint [9]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Secondary outcome [10]
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Best QoL Response for FACT-O Symptom Index (FOSI)
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Assessment method [10]
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Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.
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Timepoint [10]
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At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
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Eligibility
Key inclusion criteria
- Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- Progressive or recurrent disease after platinum-based chemotherapy
- Measurable disease by RECIST
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/09/2018
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Sample size
Target
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Accrual to date
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Final
97
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Melbourne
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Recruitment hospital [2]
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Research Site - Melbourne, Parkville
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Recruitment hospital [3]
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Research Site - Randwick
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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VIC 3050 - Melbourne, Parkville
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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Belgium
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State/province [6]
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Leuven
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Country [7]
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Germany
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State/province [7]
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Köln
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Country [8]
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Germany
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State/province [8]
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München
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Country [9]
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Israel
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State/province [9]
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Haifa
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Country [10]
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Israel
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State/province [10]
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Ramat Gan
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Country [11]
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Israel
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State/province [11]
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Tel Aviv
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Country [12]
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Poland
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State/province [12]
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Szczecin
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Country [13]
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Spain
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State/province [13]
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Barcelona
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Country [14]
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Spain
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State/province [14]
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Hospitalet deLlobregat
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Country [15]
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Sweden
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State/province [15]
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Lund
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Country [16]
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United Kingdom
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State/province [16]
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Cambridge
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Country [17]
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United Kingdom
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State/province [17]
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Edinburgh
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Country [18]
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United Kingdom
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State/province [18]
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London
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Country [19]
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United Kingdom
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State/province [19]
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Manchester
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Country [20]
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United Kingdom
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State/province [20]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00628251
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jane Robertson, BSc, MBCHB, MD
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Address
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AstraZeneca
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00628251
Download to PDF