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Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-Positive Advanced Ovarian Cancer (ICEBERG 2)

This study has been completed.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494442
First received: June 27, 2007
Last updated: May 14, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Condition Intervention Phase
Ovarian Neoplasm
 Drug: KU-0059436 (AZD2281)(PARP inhibitor)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective tumour response rate [ Time Frame: at 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit rate [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Assessed at each visit throughtout the study ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced ovarian 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494442

Locations
United States, California
Research Site
Duarte, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York, New York, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Australia
Research Site
Melbourne, Australia
Research Site
Sydney, Australia
Germany
Research Site
Cologne, Germany
Research Site
Heidelberg, Germany
Research Site
Kiel, Germany
Research Site
Munich, Germany
Spain
Research Site
Barcelona, Spain
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
London, United Kingdom
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

No publications provided by AstraZeneca

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

ClinicalTrials.gov Identifier: NCT00494442     History of Changes
Other Study ID Numbers: KU36-58, D0810C00009
Study First Received: June 27, 2007
Last Updated: May 14, 2009
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

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

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2013