Study to Assess Safety and Tolerability of AZD4547 in Japanese Patient

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Cancer; Advanced Solid Malignancies

Treatments: Drug: AZD4547

Study type: Interventional

Funder types: Industry

Identifiers

NCT01213160

D2610C00002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 25 to 150 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

AZD4547

Experimental group

Treatment:

Drug: AZD4547