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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
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
Secondary ID [1] 0 0
D0810C00009
Secondary ID [2] 0 0
KU36-58
Universal Trial Number (UTN)
Trial acronym
ICEBERG 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional(has expanded access)
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
Timepoint [1] 0 0
Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.
Secondary outcome [1] 0 0
Clinical Benefit (CB)
Timepoint [1] 0 0
End of study
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
End of study
Secondary outcome [3] 0 0
Best Percentage Change in Tumour Size
Timepoint [3] 0 0
End of study
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
End of study

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
Minimum age
18 Years
Maximum age
130 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2017
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne, Parkville
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
VIC 3050 - Melbourne, Parkville
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Germany
State/province [5] 0 0
Köln
Country [6] 0 0
Spain
State/province [6] 0 0
Hospitalet deLlobregat
Country [7] 0 0
Sweden
State/province [7] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
KuDOS Pharmaceuticals Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Carmichael, BSc MBChB MD FRCP
Address 0 0
KuDOS Pharmaceuticals Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 are available at https://clinicaltrials.gov/study/NCT00494442