Completed

A Phase I, Open-label Study to Assess the Safety and Tolerability of Doses of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

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What is being tested

olaparib

Drug
Who is being recruted

Neoplasms

From 20 to 130 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 16, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: March 25, 2013

Actual date on which the first participant was enrolled.

MTD - maximum tolerated dose

NCT01813474
Principal SponsorAstraZeneca
Last updated: January 16, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 130 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

5 inclusion criteria required to participate
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status
Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists
Subjects who agree to hospitalisation from starting olaparib to multiple dose period at day 15
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
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5 exclusion criteria prevent from participating
Subjects receiving inhibitors of CYP3A4 (cytochrome P450 3A4)
Subjects who received any previous treatment with a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, including olaparib
Subjects with a known hypersensitivity to olaparib or any of the excipients of the product
Subjects with myelodysplastic syndrome/acute myeloid leukaemia
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
olaparib tablet

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Research Site

Chūōku, JapanOpen Research Site in Google Maps

Research Site

Fukuoka, Japan

Research Site

Sapporo, Japan
Completed3 Study Centers