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

AstraZeneca58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Neoplasm

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Locations (11)

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Boston, Massachusetts, United States

Research Site

Outcomes

Primary Outcomes

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.

Time frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.

Secondary Outcomes

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)

Time frame: End of study

Duration of Response

Duration of response to olaparib

Time frame: End of study

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).

Time frame: End of study

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.

Time frame: End of study

Data from ClinicalTrials.gov

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