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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

Tracking Information
First Submitted Date  ICMJE June 27, 2007
First Posted Date  ICMJE June 29, 2007
Results First Submitted Date  ICMJE January 15, 2015
Results First Posted Date  ICMJE January 26, 2015
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE June 11, 2007
Actual Primary Completion Date March 17, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
Objective tumour response rate [ Time Frame: at 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
  • Clinical benefit rate [ Time Frame: every 2 months ]
  • Safety and tolerability [ Time Frame: Assessed at each visit throughtout the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Neoplasm
Intervention  ICMJE
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
    Other Name: Olaparib
  • Drug: KU-0059436 (AZD2281)(PARP inhibitor)
    oral
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2018)
58
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2007)
40
Actual Study Completion Date  ICMJE July 20, 2017
Actual Primary Completion Date March 17, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Spain,   Sweden,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00494442
Other Study ID Numbers  ICMJE KU36-58
D0810C00009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE KuDOS Pharmaceuticals Limited
Investigators  ICMJE
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
PRS Account AstraZeneca
Verification Date June 2018

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