A Phase I study of AZD1480 in Patients with Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the escalation phase,Non-Small Cell Lung Cancer(NSCLC) and non-smokers with lung metastasis and gastric cancer and solid tumour in the expansion phase.
Study identifier:D1060C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess the Safety and Tolerability, and Pharmacokinetics of AZD1480 in Asian Patients with Advanced Solid Malignancies and Asian Patients with Child-Pugh A to B7 Advanced Hepatocellular Carcinoma (HCC) in the escalation phase, estimated glomerular filtration rate(EGFR) or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available in the expansion phase.
Medical condition
solid tumour
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD1480 Daily, AZD1480 BID
Sex
All
Actual Enrollment
47
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Dec 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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part A Daily dosing of AZD1480 to the patients with solid tumours excluding HCC | Drug: AZD1480 Daily Oral Dose, Capsule, Daily Dosing |
| Experimental: Part B BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7) | Drug: AZD1480 BID Oral Dose, Capsule, BID Dosing |
| Experimental: Part C BID dosing of AZD1480 to the patients with solid tumours excluding HCC | Drug: AZD1480 BID Oral Dose, Capsule, BID Dosing |
| Experimental: Expansion BID dosing of AZD1480 to the patients with EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer and solid tumour with biopsy available. | Drug: AZD1480 BID Oral Dose, Capsule, BID Dosing |
Contacts
Investigators
Principal Investigator
Becker Hewes
AstraZeneca
