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

Ovarian Neoplasm Clinical Trial

— ICEBERG 2  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494442
• Other study ID #: KU36-58
• Secondary ID: D0810C00009
• Status: Completed
• Phase: Phase 2
• Start date: June 11, 2007
• Est. completion date: July 20, 2017

Study information

• Verified date: June 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 20, 2017
• Est. primary completion date: March 17, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasm
• Ovarian Neoplasms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral
• KU-0059436 (AZD2281)(PARP inhibitor)
oral

Locations

Country	Name	City	State
Australia	Research Site	Melbourne
Australia	Research Site	Melbourne, Parkville
Australia	Research Site	Randwick
Germany	Research Site	Köln
Spain	Research Site	Hospitalet deLlobregat
Sweden	Research Site	Lund
United States	Research Site	Boston	Massachusetts
United States	Research Site	Houston	Texas
United States	Research Site	Los Angeles	California
United States	Research Site	New York	New York
United States	Research Site	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	KuDOS Pharmaceuticals Limited

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)	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	Clinical Benefit (CB)	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
Secondary	Duration of Response	Duration of response to olaparib	End of study
Secondary	Best Percentage Change in Tumour Size	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
Secondary	Progression-Free Survival (PFS)	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

External Links

•   AstraZeneca Clinical Trial Information - Outside US
•   CSR_Synopsis_D0810C00009(KU36-58).pdf