Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours
Study identifier:D1060C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 Administered as Daily Oral Monotherapy in Patients With Advanced Solid Malignancies in the Escalation Phase and EGFR or ROS Mutant NSCLC or Non-Smokers with Lung Metastasis in the Expansion Phase.
Medical condition
solid malignancies
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1480
Sex
All
Actual Enrollment
38
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 01 Apr 2010
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1480 until Maximum Tolerated Dose (MTD) is reached | Drug: AZD1480 continuous daily oral capsule |
| Experimental: 2 AZD1480 dose expansion of MTD | Drug: AZD1480 continuous daily oral capsule |
Contacts
Investigators
Principal Investigator
Gregory Curt
AstraZeneca Pharmaceuticals
