Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer (ICEBERG 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494234
First received: June 27, 2007
Last updated: July 23, 2015
Last verified: July 2015

June 27, 2007
July 23, 2015
June 2007
February 2009   (final data collection date for primary outcome measure)
Confirmed Objective Tumour Response (According to RECIST Criteria) [ Time Frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy. Up to 2 years. ] [ Designated as safety issue: No ]
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: 4 months ]
Complete list of historical versions of study NCT00494234 on ClinicalTrials.gov Archive Site
  • Duration of Response to Olaparib [ Time Frame: Time from response (CR or PR) to progression per RECIST criteria ] [ Designated as safety issue: No ]
  • The Clinical Benefit Rate (CBR) [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The Clinical Benefit Rate (CBR) is defined as the percentage of patients with a RECIST tumour response of confirmed CR, PR or stable disease (SD) for ≥8 weeks +/- 1 week visit window.
  • Best Percent Change in Tumour Size [ Time Frame: End of study ] [ Designated as safety issue: No ]
    The tumour size is 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 ]
    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. Those patients who were withdrawn from the study without disease progression were regarded as censored at their last evaluable RECIST assessment. Where patients had not progressed at the termination of the study, they were also regarded as censored at their last evaluable RECIST assessment.
  • Change From Baseline in ECOG Performance Status: Improvement Rate [ Time Frame: At cycle 7 day 1 (ie, after completing 6 cycles of treatment) ] [ Designated as safety issue: No ]
    The change in ECOG performance status was defined as improved (meaning the ECOG score is less than the baseline value), no change (ECOG is same as at baseline), worsened (ECOG score is greater than the baseline value) or missing (the ECOG score is missing or was not recorded at baseline). If no measurement was recorded at Cycle 1 Day 1, the change was calculated in relation to the last recorded ECOG value prior to Day 1.
  • Clinical benefit rate [ Time Frame: every 2 months ]
  • Safety and tolerability profile [ Time Frame: assessed at each visit throught the study ]
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Breast Cancer
A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 (Olaparib) Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Breast Cancer

The purpose of the study is to see if the drug KU 0059436 (olaparib) is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced breast 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
Breast Neoplasms
  • Drug: KU-0059436 (AZD2281) (PARP inhibitor)
    oral
    Other Name: Olaparib
  • Drug: KU-0059436 (AZD2281) (PARP inhibitor)
  • Experimental: KU-0059436 (AZD2281) 100 mg BID
    KU-0059436 (AZD2281) 100 mg BID
    Intervention: Drug: KU-0059436 (AZD2281) (PARP inhibitor)
  • Experimental: KU-0059436 (AZD2281) 400 mg BID
    KU-0059436 (AZD2281) 400 mg BID
    Intervention: Drug: KU-0059436 (AZD2281) (PARP inhibitor)
Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):235-44. doi: 10.1016/S0140-6736(10)60892-6. Epub 2010 Jul 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
December 2015
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced breast 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,   Sweden,   United Kingdom
 
NCT00494234
KU36-44, D0810C00008
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
July 2015

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