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

Phase 2

Completed

• Conditions: Ovarian Neoplasm
• Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor)

• Registration Number: NCT00494442
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-11
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Primary Completion: 2009-03-17
• Disposition First Submitted: 2013-09-17
• Disposition First Submitted QC: 2013-09-17
• Disposition First Posted: 2013-09-20
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-01-26
• Study Completion: 2017-07-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KU-0059436 (AZD2281) 100 mg BID	KU-0059436 (AZD2281)(PARP inhibitor)	-
KU-0059436 (AZD2281) 400 mg BID	KU-0059436 (AZD2281)(PARP inhibitor)	-

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	End of study	Duration of response to olaparib
Best Percentage Change in Tumour Size	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).
Clinical Benefit (CB)	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)
Progression-Free Survival (PFS)	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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden