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Completed

NCT Number: NCT00628251

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fanconi Anemia, Complementation Group D1 Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, East Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2281

Drug

400mg Oral twice daily

Other names: Olaparib

Liposomal Doxorubicin

Drug

50mg/m2 Monthly Intravenous

Other names: Doxil®

Primary outcomes

  1. Progression Free Survival (PFS)

    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)

    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)

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

    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.

  2. 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)

    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

  3. Overall 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)

    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.)

  4. 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)

    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

  5. 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)

    Best percentage change in cancer antigen 125 (CA-125) levels

  6. 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)

    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.

  7. Overall Survival (OS)

    Time frame: At the time of the cut-off for the final analysis of overall survival (30 April 2010)

    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

  8. 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)

    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.

  9. 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)

    Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.

  10. 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)

    Best HRQoL response using the FOSI endpoint. Improvement was defined as a change from baseline of greater than or equal to +3.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ICEBERG 3

Important dates

Study start
2008
Primary completion
2009
Study completion
2018
First posted
Mar 5, 2008
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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