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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00494442
Registration number
NCT00494442
Ethics application status
Date submitted
27/06/2007
Date registered
29/06/2007
Date last updated
1/08/2018
Titles & IDs
Public title
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
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Scientific 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
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Secondary ID [1]
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D0810C00009
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Secondary ID [2]
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KU36-58
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Universal Trial Number (UTN)
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Trial acronym
ICEBERG 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasm
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - KU-0059436 (AZD2281)(PARP inhibitor)
Treatment: Drugs - KU-0059436 (AZD2281)(PARP inhibitor)
Experimental: KU-0059436 (AZD2281) 100 mg BID -
Experimental: KU-0059436 (AZD2281) 400 mg BID -
Treatment: Drugs: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Treatment: Drugs: KU-0059436 (AZD2281)(PARP inhibitor)
oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.
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Secondary outcome [1]
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Clinical Benefit (CB)
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Assessment method [1]
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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)
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Timepoint [1]
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End of study
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Duration of response to olaparib
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Timepoint [2]
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End of study
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Secondary outcome [3]
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Best Percentage Change in Tumour Size
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Assessment method [3]
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The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
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Timepoint [3]
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End of study
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Secondary outcome [4]
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Progression-Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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End of study
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/06/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2017
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Sample size
Target
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Accrual to date
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Final
58
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Melbourne, Parkville
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - Randwick
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Recruitment postcode(s) [1]
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VIC 3050 - Melbourne, Parkville
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Germany
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State/province [5]
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Köln
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Country [6]
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Spain
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State/province [6]
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Hospitalet deLlobregat
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Country [7]
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Sweden
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State/province [7]
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Lund
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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KuDOS Pharmaceuticals Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT00494442
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Trial related presentations / publications
Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8. Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6. Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, Weitzel JN, Oaknin A, Loman N, Lu K, Schmutzler RK, Matulonis U, Wickens M, Tutt A. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):245-51. doi: 10.1016/S0140-6736(10)60893-8. Epub 2010 Jul 6.
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Public notes
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Contacts
Principal investigator
Name
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James Carmichael, BSc MBChB MD FRCP
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Address
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KuDOS Pharmaceuticals Limited
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00494442
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