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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
D0810C00012
Universal Trial Number (UTN)
Trial acronym
ICEBERG 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
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 outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [2] 0 0
Disease Control Rate
Timepoint [2] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [3] 0 0
Overall Duration of Response
Timepoint [3] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [4] 0 0
Best Percentage Change in Tumour Size
Timepoint [4] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [5] 0 0
Best Percentage Change From Baseline in CA-125 Levels
Timepoint [5] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [6] 0 0
Confirmed RECIST Response and/or CA-125 Response
Timepoint [6] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [7] 0 0
Overall Survival (OS)
Timepoint [7] 0 0
At the time of the cut-off for the final analysis of overall survival (30 April 2010)
Secondary outcome [8] 0 0
Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)
Timepoint [8] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [9] 0 0
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
Timepoint [9] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
Secondary outcome [10] 0 0
Best QoL Response for FACT-O Symptom Index (FOSI)
Timepoint [10] 0 0
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

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
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2018
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment hospital [2] 0 0
Research Site - Melbourne, Parkville
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
VIC 3050 - Melbourne, Parkville
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Germany
State/province [7] 0 0
Köln
Country [8] 0 0
Germany
State/province [8] 0 0
München
Country [9] 0 0
Israel
State/province [9] 0 0
Haifa
Country [10] 0 0
Israel
State/province [10] 0 0
Ramat Gan
Country [11] 0 0
Israel
State/province [11] 0 0
Tel Aviv
Country [12] 0 0
Poland
State/province [12] 0 0
Szczecin
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Hospitalet deLlobregat
Country [15] 0 0
Sweden
State/province [15] 0 0
Lund
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Edinburgh
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Manchester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Robertson, BSc, MBCHB, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00628251