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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-11

Study Completion Date

2017-07-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KU-0059436 (AZD2281) 100 mg BID

Group Type EXPERIMENTAL

KU-0059436 (AZD2281)(PARP inhibitor)

Intervention Type DRUG

oral

KU-0059436 (AZD2281) 400 mg BID

Group Type EXPERIMENTAL

KU-0059436 (AZD2281)(PARP inhibitor)

Intervention Type DRUG

oral

Interventions

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KU-0059436 (AZD2281)(PARP inhibitor)

oral

Intervention Type DRUG

KU-0059436 (AZD2281)(PARP inhibitor)

oral

Intervention Type DRUG

Other Intervention Names

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Olaparib

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No