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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)

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ClinicalTrials.gov Identifier: NCT00494442
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : January 26, 2015
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Neoplasm Drug: KU-0059436 (AZD2281)(PARP inhibitor) Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Actual Study Start Date : June 11, 2007
Actual Primary Completion Date : March 17, 2009
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Olaparib

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. ]
    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 :
  1. Clinical Benefit (CB) [ Time Frame: End of study ]
    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)

  2. Duration of Response [ Time Frame: End of study ]
    Duration of response to olaparib

  3. Best Percentage Change in Tumour Size [ Time Frame: End of study ]
    The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494442


Locations
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United States, California
Research Site
Los Angeles, California, United States, 90048
Research Site
San Francisco, California, United States, 94115
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, Texas
Research Site
Houston, Texas, United States, 77030
Australia
Research Site
Melbourne, Parkville, Australia, VIC 3050
Research Site
Melbourne, Australia, 3000
Research Site
Randwick, Australia, 2031
Germany
Research Site
Köln, Germany, 50931
Spain
Research Site
Hospitalet deLlobregat, Spain, 08907
Sweden
Research Site
Lund, Sweden, S-221 85
Sponsors and Collaborators
AstraZeneca
KuDOS Pharmaceuticals Limited
Investigators
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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
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Additional Information:

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

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494442    
Other Study ID Numbers: KU36-58
D0810C00009
First Posted: June 29, 2007    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: August 1, 2018
Last Verified: June 2018
Keywords provided by AstraZeneca:
Advanced ovarian cancer
Poly(ADP ribose) polymerases
KU-0059436
 AZD2281
BRCA1 protein
BRCA2 protein
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents