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Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer (ICEBERG 3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628251
First received: February 26, 2008
Last updated: August 24, 2016
Last verified: August 2016

February 26, 2008
August 24, 2016
July 2008
September 2009   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) [ Time Frame: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)
Efficacy comparison of 400 mg bd, 100 mg bd and 100 mg od AZD2281 v 50mg/m2 doxil every 4 weeks in BRCA1 or 2 associated advanced ovarian cancer patients by PFS (primary variable), ORR, duration of response and CA-125 levels (secondary variables) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628251 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumours - RECIST) [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
  • Duration of Response [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)
  • Best Percentage Change in Tumour Size [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    The percentage change (reduction) from baseline in the sum of the lengths of the longest diameter (LD) of the RECIST target lesions were objectively documented, regardless of whether the patient was still taking study medication
  • Best Percentage Change From Baseline in CA-125 Levels [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    Best percentage change in cancer antigen 125 (CA-125) levels
  • Confirmed RECIST Response and/or CA-125 Response [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.
  • Disease Control Rate [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    The number of patients with confirmed CR (disappearance of all target lesions) or PR (30% decrease in the sum of the longest diameter of target lesions ) or SD ( small changes ) >4 months, divided by the number of randomised patients
  • Overall Survival (OS) [ Time Frame: At the time of the cut-off for the final analysis of overall survival (30 April 2010) ] [ Designated as safety issue: No ]
    OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals
  • Best Quality of Life (QoL) Response for Trial Outcome Index (TOI) [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    Best HRQoL response using the TOI endpoint. Improvement was defined as a change from baseline of greater than or equal to +7. The TOI score ranges from 0-100.
  • Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O) [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.
  • Best QoL Response for FACT-O Symptom Index (FOSI) [ Time Frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009) ] [ Designated as safety issue: No ]
    Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.
Comparison of safety and tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
  • Drug: AZD2281
    400mg Oral twice daily
    Other Name: Olaparib
  • Drug: Liposomal Doxorubicin
    50mg/m2 Monthly Intravenous
    Other Name: Doxil®
  • Drug: AZD2281
    200mg oral twice daily
  • Experimental: 1
    AZD2281 Oral 200 mg BID
    Intervention: Drug: AZD2281
  • Active Comparator: 2
    Liposomal Doxorubicin
    Intervention: Drug: Liposomal Doxorubicin
  • Experimental: 3
    AZD2281 Oral 400 mg BID
    Intervention: Drug: AZD2281

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
December 2016
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced ovarian cancer with positive BRCA1 or BRCA2 status
  • Progressive or recurrent disease after platinum-based chemotherapy
  • Measurable disease by RECIST

Exclusion Criteria:

  • Previous anthracycline treatment
  • 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 to 130 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Germany,   Israel,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT00628251
D0810C00012
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi Royal Marsden NHS Foundation Trust
AstraZeneca
August 2016

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