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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00494234




Registration number
NCT00494234
Ethics application status
Date submitted
27/06/2007
Date registered
29/06/2007
Date last updated
31/05/2019

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer
Scientific title
A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 (Olaparib) Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Breast Cancer
Secondary ID [1] 0 0
D0810C00008
Secondary ID [2] 0 0
KU36-44
Universal Trial Number (UTN)
Trial acronym
ICEBERG 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KU-0059436 (AZD2281) (PARP inhibitor)
Treatment: Drugs - KU-0059436 (AZD2281) (PARP inhibitor)

Experimental: KU-0059436 (AZD2281) 100 mg BID -

Experimental: KU-0059436 (AZD2281) 400 mg BID -


Treatment: Drugs: KU-0059436 (AZD2281) (PARP inhibitor)
oral

Treatment: Drugs: KU-0059436 (AZD2281) (PARP inhibitor)


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Tumour Response (According to RECIST Criteria) - Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Timepoint [1] 0 0
Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years.
Secondary outcome [1] 0 0
Duration of Response to Olaparib
Timepoint [1] 0 0
Time from response (CR or PR) to progression per RECIST criteria
Secondary outcome [2] 0 0
The Clinical Benefit Rate (CBR) - The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for =8 weeks +/- 1 week visit window.
Timepoint [2] 0 0
End of study
Secondary outcome [3] 0 0
Best Percent Change in Tumour Size - The tumour size is defined as the sum of the longest diameters as measured among all target lesions.
Timepoint [3] 0 0
End of study
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) - PFS is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.
Timepoint [4] 0 0
End of study
Secondary outcome [5] 0 0
Change From Baseline in ECOG Performance Status: Improvement Rate - The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.
Timepoint [5] 0 0
At cycle 7 day 1 (ie, after completing 6 cycles of treatment)

Eligibility
Key inclusion criteria
- Advanced breast cancer with positive BRCA1 or BRCA2 status

- Failed at least one prior chemotherapy

- In investigators opinion, no curative standard therapy exists

- Measurable disease
Minimum age
18 Years
Maximum age
130 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Non-randomised 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment hospital [2] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 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
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Germany
State/province [6] 0 0
Köln
Country [7] 0 0
Sweden
State/province [7] 0 0
Lund
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cambridge
Country [9] 0 0
United Kingdom
State/province [9] 0 0
London
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
KuDOS Pharmaceuticals Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well
tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast
cancer and for whom no curative therapeutic option exists.
Trial website
https://clinicaltrials.gov/show/NCT00494234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Carmichael, BSc, MBChB, MD, FRCP
Address 0 0
KuDOS Pharmaceuticals Limited
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

Summary results
Other publications