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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: August 1, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Drug: KU-0059436 (AZD2281) (PARP inhibitor) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ]
    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.


Secondary Outcome Measures:
  • Duration of Response to Olaparib [ Time Frame: Time from response (CR or PR) to progression per RECIST criteria ]
  • The Clinical Benefit Rate (CBR) [ Time Frame: End of study ]
    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.

  • Best Percent Change in Tumour Size [ Time Frame: End of study ]
    The tumour size is defined as the sum of the longest diameters as measured among all target lesions.

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

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


Enrollment: 54
Actual Study Start Date: June 15, 2007
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: February 27, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KU-0059436 (AZD2281) 100 mg BID Drug: KU-0059436 (AZD2281) (PARP inhibitor)
oral
Other Name: Olaparib
Experimental: KU-0059436 (AZD2281) 400 mg BID Drug: KU-0059436 (AZD2281) (PARP inhibitor)

  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494234

Locations
United States, California
Research Site
Los Angeles, California, United States, 90048
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02115
United States, New York
Research Site
New York, New York, United States, 10065
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104-4322
United States, Texas
Research Site
Dallas, Texas, United States, 75390-9121
Australia
Research Site
Melbourne, Australia, 3000
Research Site
Randwick, Australia, 2031
Germany
Research Site
Köln, Germany, 50924
Sweden
Research Site
Lund, Sweden, 221 85
United Kingdom
Research Site
Cambridge, United Kingdom, CB2 0QQ
Research Site
London, United Kingdom, SE1 9RT
Research Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AstraZeneca
KuDOS Pharmaceuticals Limited
Investigators
Study Director: James Carmichael, BSc, MBChB, MD, FRCP KuDOS Pharmaceuticals Limited
Principal Investigator: Andrew Tutt, PhD MRCP FRCR Guy's and St Thomas's NHS Foundation Trust, London, UK
  More Information

Additional Information:
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: August 1, 2017

Keywords provided by AstraZeneca:
Advanced breast cancer
Poly(ADP ribose) polymerases
AZD2281,KU-0059436 (olaparib)
BRCA1 protein
BRCA2 protein

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 21, 2017