Open Label, Dose Escalation Phase I Study of AZD2281

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Advanced Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

* 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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No