NCT01219543

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.

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.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is Phase I, open-label and dose escalation study to evaluate the safety and tolerability of AZD1480(JAK2 inhibitor) in Asian patients with advanced solid tumors (Part A and C) and in patients with advanced HCC (Part B) in the escalation phase, EGFR or ROS mutant NSCLC and non-smokers with lung metastasis and gastric cancer in the expansion phase and to evaluate daily and BID dosing.

Conditions

• Solid Tumour
• Advanced Solid Malignancies
• Child-Pugh A to B7 Advanced Hepatocellular Carcinoma
• EGFR and/or ROS Mutant NSCLC
• Lung Metastasis Carcinoma
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	AZD1480 Daily	Oral Dose, Capsule, Daily Dosing
DRUG	AZD1480 BID	Oral Dose, Capsule, BID Dosing

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-10-13
• Last updated: 2013-01-08

Locations

1 site across 1 country: South Korea