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

June 27, 2007
August 29, 2014
June 2007
March 2009   (final data collection date for primary outcome measure)
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.
Objective tumour response rate [ Time Frame: at 4 months ]
Complete list of historical versions of study NCT00494442 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasm
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2014
March 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Germany,   Spain,   Sweden
 
NCT00494442
KU36-58, D0810C00009
Yes
AstraZeneca
AstraZeneca
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
AstraZeneca
August 2014

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