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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/NCT00494234
Registration number
NCT00494234
Ethics application status
Date submitted
27/06/2007
Date registered
29/06/2007
Date last updated
19/01/2024
Titles & IDs
Public title
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
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Scientific title
A Phase II, Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU-0059436 Given Orally Twice Daily in Patients With Advanced BRCA1- or BRCA2-associated Breast Cancer.
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Secondary ID [1]
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D0810C00008
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Secondary ID [2]
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KU36-44
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Universal Trial Number (UTN)
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Trial acronym
ICEBERG 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Olaparib
Experimental: Olaparib 100 mg - Participants will receive two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.
Experimental: Olaparib 400 mg - Participants will receive eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.
Treatment: Drugs: Olaparib
Participants will receive capsules of olaparib orally as stated in arm description.
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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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Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
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Assessment method [1]
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The ORR is the percentage of participants whose best tumor response is either complete response (CR) or partial response (PR), according to the RECIST v1.0 criteria. The CR is defined as disappearance of all target lesions (TLs). The PR is defined as at least a 30% decrease in the sum of longest diameters (LD) taking as reference the baseline sum of LD. Percentage of participants with ORR is reported.
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Timepoint [1]
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Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)
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Secondary outcome [1]
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Duration of Response (DoR) to Olaparib
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Assessment method [1]
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Duration of response is defined as the date of progression per RECIST criteria - the date when CR or PR [whichever is earliest] is confirmed + 1. The CR is defined as disappearance of all TLs. The PR is defined as at least a 30% decrease in the sum of LD taking as reference the baseline sum of LD. Duration of response was analyzed for those participants who had OR.
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Timepoint [1]
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Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)
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Secondary outcome [2]
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Clinical Benefit Rate (CBR)
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Assessment method [2]
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The CBR is defined as the percentage of participants with a RECIST tumor response of confirmed CR, PR or stable disease (SD) for = 8 weeks +/- 1 week visit window. The CR is defined as disappearance of all TLs. The PR is defined as at least a 30% decrease in the sum of LD taking as reference the baseline sum of LD. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum of LD since the treatment started.
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Timepoint [2]
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From Day 1 of Cycle 3 through study withdrawal (approximately up to 2 years)
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Secondary outcome [3]
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Best Percentage Change in Tumor Size
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Assessment method [3]
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The tumor size is defined as the sum of the longest diameters as measured among all target lesions. At each assessment, the percentage change in tumor size is defined as 100 × 1 - (sum of all target lesion diameters at visit/sum of all target lesion diameters at baseline).
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Timepoint [3]
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Baseline (Days -28 to 0) through study withdrawal (approximately up to 2 years)
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Secondary outcome [4]
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Progression-free Survival (PFS)
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Assessment method [4]
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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 participants who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where participants had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment. PFS was analyzed using Kaplan-Meier estimate.
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Timepoint [4]
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Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years)
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Secondary outcome [5]
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Number of Participants With Improvement in Eastern Co-operative Oncology Group (ECOG) Performance Status Total Score From Baseline
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Assessment method [5]
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ECOG performance status is used by researchers to assess how a participant's disease is progressing. The scores are: 0=Fully Active, able to carry out work without restrictions; 1=Restricted activity and able to carry out light work or sedentary nature; 2=capable of self-care but unable to carry out work activities; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely Disabled, and totally confined to bed or chair; 5=Dead. Change in ECOG performance status was defined as improved (less than the baseline value), no change (same as at baseline), worsened (greater than the baseline value) or missing (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.
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Timepoint [5]
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Screening (Days -7 to 0), Day 1 Cycle 7 (ie, after completing 6 cycles of treatment) and study withdrawal (approximately up to 2 years).
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Secondary outcome [6]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [6]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
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Timepoint [6]
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Day 1 through Day 480 (maximum observed duration)
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Secondary outcome [7]
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Number of Participants With Clinically Significant Changes in Vital Signs From Baseline
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Assessment method [7]
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Number of participants with clinically significant changes in vital signs are reported. Vital sign parameters included body temperature, blood pressure, and pulse rate.
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Timepoint [7]
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Day 1 through Day 480 (maximum observed duration)
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Secondary outcome [8]
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Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters
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Assessment method [8]
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Number of participants with at least 2-grade change from baseline to worst toxicity grade in clinical laboratory parameters are reported. Laboratory parameters included hematology, clinical chemistry, and urinalysis.
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Timepoint [8]
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Day 1 through Day 480 (maximum observed duration)
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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
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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
- 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
Non-randomised 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
15/06/2007
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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
21/12/2022
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Sample size
Target
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Accrual to date
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Final
54
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment hospital [2]
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Research Site - Randwick
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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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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Massachusetts
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Country [3]
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Canada
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State/province [3]
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CA
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Country [4]
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Germany
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State/province [4]
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Kiel
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Country [5]
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Germany
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State/province [5]
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Köln
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Country [6]
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Germany
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State/province [6]
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München
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Country [7]
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Israel
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State/province [7]
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Tel-Aviv
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Country [8]
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Spain
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State/province [8]
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Hospitalet deLlobregat
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Country [9]
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Spain
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State/province [9]
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Madrid
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Country [10]
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Sweden
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State/province [10]
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Lund
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Country [11]
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United Kingdom
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State/province [11]
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Cambridge
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Country [12]
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United Kingdom
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State/province [12]
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Edinburgh
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Country [13]
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United Kingdom
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State/province [13]
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Fulham
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Country [14]
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United Kingdom
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State/province [14]
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London
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Country [15]
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United Kingdom
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State/province [15]
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Manchester
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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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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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KuDOS Pharmaceuticals Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well
tolerated in treating participants with measurable breast cancer gene (BRCA)1- or
BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00494234
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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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James Carmichael, BSc, MBChB, MD, FRCP
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Address
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KuDOS Pharmaceuticals Limited
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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/NCT00494234
Download to PDF