Open Label Phase 1 Study in Japan for patient with advanced solid malignancies

Study identifier:D3610C00004

ClinicalTrials.gov identifier:NCT01353781

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Japanese Patients with Advanced Solid Malignancies

Medical condition

Advanced solid malignancy

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD5363

Sex

All

Actual Enrollment

39

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Jul 2014
Study Completion Date: 01 Jul 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria