A Phase I, Dose-Escalation Study to Assess the Safety and Drug Levels in Blood of AZD4877 in Japanese Adult Patients

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-06-30

Brief Summary

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The primary purpose of this study is to evaluate the safety and tolerability of AZD4877 on a weekly schedule in Japanese patients with advanced solid malignancies

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Detailed Description

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Conditions

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Cancer Tumors Carcinoma

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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AZD4877

10 mg IV (3 weeks treatment 1 week rest)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with solid tumour but which have no standard treatment or did not respond to previous treatments.
* Patients who usually have mild symptoms capable of walking and light and sedentary work.
* Patients who can stay in hospital at least during 4 weeks.

Exclusion Criteria

* Patients who have received treatment with anti-cancer agent within 4 weeks prior to first dose of study treatment; 6 weeks if the anti-cancer agent is mitomycin.
* Patients with abnormally low levels of neutrophil count, platelet count, or haemoglobin, indicators of bone marrow function.
* Patients who received therapeutic radiotherapy at central nervous system within 3 months prior to first dose of study treatment; the other sites within 4 weeks; or local site within 2 weeks.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No