This trial is active, not recruiting.

Condition ovarian neoplasm
Treatments ku-0059436 (azd2281)(parp inhibitor)
Phase phase 2
Sponsor AstraZeneca
Collaborator KuDOS Pharmaceuticals Limited
Start date June 2007
End date March 2009
Trial size 70 participants
Trial identifier NCT00494442, D0810C00009, KU36-58


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
ku-0059436 (azd2281)(parp inhibitor) Olaparib
ku-0059436 (azd2281)(parp inhibitor)

Primary Outcomes

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.

Secondary Outcomes

Clinical Benefit (CB)
time frame: End of study
Duration of Response
time frame: End of study
Best Percentage Change in Tumour Size
time frame: End of study
Progression-Free Survival (PFS)
time frame: End of study

Eligibility Criteria

Female participants from 18 years up to 130 years old.

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

Additional Information

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
Principal investigator Andrew Tutt, PhD MRCP FRCR
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.