Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-25

Study Completion Date

2016-08-31

Brief Summary

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The objective of this study will be to investigate the safety and tolerability of olaparib tablet when given orally to Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of olaparib will be investigated.

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Detailed Description

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MTD - maximum tolerated dose

Conditions

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Cancer Advanced Solid Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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olaparib tablet monotherapy

olaparib tablet

Group Type EXPERIMENTAL

olaparib

Intervention Type DRUG

tablet oral

Interventions

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olaparib

tablet oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
* Subjects who have overall good overall general condition.
* Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15.
* Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
* Subjects who have at least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI at baseline and follow up visits

Exclusion Criteria

* Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib.
* Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4).
* Subjects with symptomatic uncontrolled brain metastases.
* Subjects with myelodysplastic syndrome/acute myeloid leukaemia.
* Subjects with a known hypersensitivity to olaparib or any of the excipients of the product.

Minimum Eligible Age

20 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No