Open Label, Dose Escalation Phase I Study of AZD2281

August 19, 2009 updated by: AstraZeneca

A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies

Study Overview

Status

Completed

Conditions

Advanced Solid Malignancies

Intervention / Treatment

Drug: KU-0059436 (AZD2281)(PARP inhibitor)

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this study is to determine the safety and tolerability of AZD2281. Time Frame: assessed after each visit	assessed after each visit

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. Time Frame: assessed after each visit	assessed after each visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: James Carmichael, KuDOS/AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Yamamoto N, Nokihara H, Yamada Y, Goto Y, Tanioka M, Shibata T, Yamada K, Asahina H, Kawata T, Shi X, Tamura T. A Phase I, dose-finding and pharmacokinetic study of olaparib (AZD2281) in Japanese patients with advanced solid tumors. Cancer Sci. 2012 Mar;103(3):504-9. doi: 10.1111/j.1349-7006.2011.02179.x. Epub 2012 Jan 30.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria