Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer (ICEBERG 2)

July 4, 2018 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia, 3000
        • Research Site
      • Melbourne, Parkville, Australia, VIC 3050
        • Research Site
      • Randwick, Australia, 2031
        • Research Site
  • Germany
      • Köln, Germany, 50931
        • Research Site
  • Spain
      • Hospitalet deLlobregat, Spain, 08907
        • Research Site
  • Sweden
      • Lund, Sweden, S-221 85
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: KU-0059436 (AZD2281) 100 mg BID
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Names:
  • Olaparib
EXPERIMENTAL: KU-0059436 (AZD2281) 400 mg BID
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Names:
  • Olaparib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
End of study
Duration of Response
Time Frame: End of study
Duration of response to olaparib
End of study
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).
End of study
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.
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

KuDOS Pharmaceuticals Limited

Investigators

  • Study Director: James Carmichael, BSc MBChB MD FRCP, KuDOS Pharmaceuticals Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 11, 2007

Primary Completion (ACTUAL)

March 17, 2009

Study Completion (ACTUAL)

July 20, 2017

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (ESTIMATE)

June 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU36-58
  • D0810C00009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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