NCT00979134

Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD4547 in Patients With Advanced Solid Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 25 Years – 149 Years
• Healthy volunteers: Not accepted

Summary

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.

Conditions

• Cancer
• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	AZD4547	Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily
DRUG	AZD4547	Patients start at a dose of 80 mg twice daily, with no washout
DRUG	AZD4547	Single dose is followed by washout 5-10 days before multiple dose

Timeline

• Start date: 2009-10-21
• Primary completion: 2014-02-12
• Completion: 2015-03-05
• First posted: 2009-09-17
• Last updated: 2019-03-15
• Results posted: 2019-03-15

Locations

29 sites across 7 countries: United States, France, Germany, Italy, Netherlands, Spain, United Kingdom