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Completed

NCT Number: NCT00494442

Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced 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.

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Key information

Conditions

Ovarian Neoplasm 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 Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–130 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Melbourne, Australia

Loading trial locations.

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
  • 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

Treatment and study plan

KU-0059436 (AZD2281)(PARP inhibitor)

Drug

oral

Other names: Olaparib

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Duration of Response

    Time frame: End of study

    Duration of response to olaparib

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • KuDOS Pharmaceuticals Limited

Registry information

Official study title

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

Acronym: ICEBERG 2

Important dates

Study start
2007
Primary completion
2009
Study completion
2017
First posted
Jun 29, 2007
Registry last updated
Aug 1, 2018

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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