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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494442
First received: June 27, 2007
Last updated: August 29, 2014
Last verified: August 2014
  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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Confirmed objective tumour response (according to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Number of patients with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.


Secondary Outcome Measures:
  • Clinical Benefit (CB) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)

  • Duration of response [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Duration of response to olaparib

  • Best percentage change in tumour size [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).

  • Progression-Free Survival (PFS) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    Progression-Free Survival (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.


Enrollment: 70
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: March 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)
oral

  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
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: NCT00494442

Locations
United States, California
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, Texas
Research Site
Houston, Texas, United States
Australia
Research Site
East Melbourne, Australia
Research Site
Melbourne, Parkville, Australia
Research Site
Randwick, Australia
Germany
Research Site
Köln, Germany
Spain
Research Site
Hospitalet deLlobregat(Barcelo, Spain
Sweden
Research Site
Lund, Sweden
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):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494442     History of Changes
Other Study ID Numbers: KU36-58, D0810C00009
Study First Received: June 27, 2007
Last Updated: August 29, 2014
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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on October 19, 2014