Study identifier:D1060C00004
ClinicalTrials.gov identifier:NCT01219543
EudraCT identifier:N/A
CTIS identifier:N/A
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.
solid tumour
Phase 1
No
AZD1480 Daily, AZD1480 BID
All
47
Interventional
18 Years - 150 Years
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
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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.
Location
Location
Seoul, Republic of Korea
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 |
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