Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-06-30

Brief Summary

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The primary purpose of this study is to explore the safety and tolerability of AZD4547 in Japanese patients with advanced solid malignancies.

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Detailed Description

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A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Japanese Patients with Advanced Solid Malignancies.

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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AZD4547

Group Type EXPERIMENTAL

AZD4547

Intervention Type DRUG

film coated tablet, PO, twice daily

Interventions

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AZD4547

film coated tablet, PO, twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Japanese patients with advanced solid malignancies Over 25 years old Relatively good overall health other than cancer

Exclusion Criteria

\- Poor bone marrow function (not producing enough blood cells). Poor liver or kidney function. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the IP or previous significant bowel resection.

Minimum Eligible Age

25 Years

Maximum Eligible Age

150 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No