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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00494442
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : January 26, 2015
Last Update Posted : October 16, 2017
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):

June 27, 2007
June 29, 2007
January 15, 2015
January 26, 2015
October 16, 2017
June 11, 2007
March 17, 2009   (Final data collection date for primary outcome measure)
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.
Objective tumour response rate [ Time Frame: at 4 months ]
Complete list of historical versions of study NCT00494442 on Archive Site
  • 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)
  • Duration of Response [ Time Frame: End of study ]
    Duration of response to olaparib
  • 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).
  • 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.
  • Clinical benefit rate [ Time Frame: every 2 months ]
  • Safety and tolerability [ Time Frame: Assessed at each visit throughtout the study ]
Not Provided
Not Provided
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
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
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Neoplasm
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    Other Name: Olaparib
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Experimental: KU-0059436 (AZD2281) 100 mg BID
    Intervention: Drug: KU-0059436 (AZD2281)(PARP inhibitor)
  • Experimental: KU-0059436 (AZD2281) 400 mg BID
    Intervention: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 20, 2017
March 17, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 130 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Spain,   Sweden,   United States
United Kingdom
Not Provided
Not Provided
KuDOS Pharmaceuticals Limited
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
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP