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Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494234
First received: June 27, 2007
Last updated: November 28, 2016
Last verified: November 2016
Results First Received: January 16, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Drug: KU-0059436 (AZD2281) (PARP inhibitor)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on June 15, 2007 and efficacy and safety data were collected up to the data cut-off of February 27, 2009. Patients were enrolled at 16 centres in 6 countries: Australia, Germany, Spain, Sweden, UK and the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two cohorts of up to 27 women with BRCA1- or BRCA2-associated breast cancer who had failed at least one prior chemotherapy and/or endocrine therapy in the advanced/metastatic setting, were assigned to receive olaparib 100 mg bd or 400 mg bd. Enrolment into the 2 cohorts was sequential with the 400 mg bd cohort being recruited first.

Reporting Groups
  Description
Olaparib 100 mg bd Full Analysis Set
Olaparib 400 mg bd Full Analysis Set

Participant Flow:   Overall Study
    Olaparib 100 mg bd   Olaparib 400 mg bd
STARTED   27   27 
COMPLETED   12   17 
NOT COMPLETED   15   10 
Lack of Efficacy                12                9 
Withdrawal by Subject                1                0 
Death                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD2281 100 mg No text entered.
AZD2281 400 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   AZD2281 100 mg   AZD2281 400 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   27   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.7  (11.99)   44.7  (9.55)   44.7  (10.74) 
Age, Customized 
[Units: Participants]
     
<35 years   7   3   10 
>=35 - <50 years   11   18   29 
>=50 - <65 years   6   5   11 
>=65 years   3   1   4 
Gender 
[Units: Participants]
     
Female   27   27   54 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   1   2 
Black or african american   1   0   1 
White   25   26   51 


  Outcome Measures
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1.  Primary:   Confirmed Objective Tumour Response (According to RECIST Criteria)   [ Time Frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years. ]

2.  Secondary:   Duration of Response to Olaparib   [ Time Frame: Time from response (CR or PR) to progression per RECIST criteria ]

3.  Secondary:   The Clinical Benefit Rate (CBR)   [ Time Frame: End of study ]

4.  Secondary:   Best Percent Change in Tumour Size   [ Time Frame: End of study ]

5.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: End of study ]

6.  Secondary:   Change From Baseline in ECOG Performance Status: Improvement Rate   [ Time Frame: At cycle 7 day 1 (ie, after completing 6 cycles of treatment) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trial Transparency
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494234     History of Changes
Other Study ID Numbers: KU36-44
D0810C00008
Study First Received: June 27, 2007
Results First Received: January 16, 2015
Last Updated: November 28, 2016
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Spain: Spanish Agency of Medicines