Study identifier:D3610C00004
ClinicalTrials.gov identifier:NCT01353781
EudraCT identifier:N/A
CTIS identifier:N/A
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
Advanced solid malignancy
Phase 1
No
AZD5363
All
39
Interventional
20 Years +
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2016 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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The purpose of this study is 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.
Location
Location
Chuo-ku, Japan
Arms | Assigned Interventions |
---|---|
Experimental: AZD5363 Ascending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD) | Drug: AZD5363 Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout. |
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