NCT01353781

Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Malignancy
• Advanced Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-05-16
• Last updated: 2016-04-26

Locations

1 site across 1 country: Japan