Study is designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced tumours
Study identifier:D2610C00001
ClinicalTrials.gov identifier:NCT00979134
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
cancer
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD4547
Sex
All
Actual Enrollment
95
Study type
Interventional
Age
25 Years - 149 Years
Date
Study Start Date: 21 Oct 2009
Primary Completion Date: 12 Feb 2014
Study Completion Date: 05 Mar 2015
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2018 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A Ascending doses of AZD4547 administered orally to patients to define the maximum tolerated dose (MTD) and/or a continuous, tolerable Recommended Dose (RD) | Drug: AZD4547 Single dose is followed by washout 5-10 days before multiple dose |
| Experimental: Part B Dose expansion phase, at the RD defined in Part A | Drug: AZD4547 Single dose is followed by washout 5-10 days before multiple dose, and at dose of 80mg twice daily |
| Experimental: Part C Expansion phase in patients with FGFR1 and FGFR2 amplified tumours commencing at the RD defined from Part A | Drug: AZD4547 Patients start at a dose of 80 mg twice daily, with no washout |
Contacts
Investigators
Principal Investigator
Fabrice André
Institut de cancérologie Gustave Roussy
