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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01219543

Enrollment

Registered

2010-10-13

Start date

2010-11-30

Completion date

2012-12-31

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Advanced solid malignancies, Child-Pugh A to B7 advanced hepatocellular carcinoma, EGFR and/or ROS mutant NSCLC, Non-smokers with lung metastasis, Gastric cancer, Solid tumour, AZD1480, JAK1/JAK2 kinase inhibitor

Brief 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.

Interventions

DRUGAZD1480 Daily

Oral Dose, Capsule, Daily Dosing

DRUGAZD1480 BID

Oral Dose, Capsule, BID Dosing

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female aged 18 years or older * For Part A and C: Histological or cytological confirmation of a solid malignant tumour refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded. * For Expansion : Histological or cytological confirmation of * Expansion 1: EGFR and/or ROS mutant NSCLC or Non-smokers with lung metastasis * Expansion 2: Gastric cancer or solid tumour with biopsy available (consenting paired biopsies)refractory to standard therapies or for which no standard therapies exist. Patients with lymphoma & HCC are excluded. * For Part B : Advanced or metastatic HCC, unresectable and incurable with ablative therapy or TACE, with no standard therapy available. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with no deterioration over the previous 2 weeks * For Part B : Child-Pugh liver function status classified as A to B7

Exclusion criteria

* For any other chemotherapy, immunotherapy or anticancer agents, within 5 half lives or 3 weeks must have elapsed from treatment to of the first dose of investigational product, whichever is shorter. * With the exception of alopecia, any unresolved toxicities from prior therapy ≥ Grade 2 of CTCAE V4.02 at the time of starting study (except LFTs for HCC patients, which may be Grade 2 at the time of starting the study) * Any of the following conditions:Interferon treatment for HBV and HCV Prior Liver Transplantation * Inadequate bone marrow reserve or organ function as demonstrated by laboratory values * Evidence of established interstitial lung disease(ILD) on baseline high resolution computerized tomography(HRCT)

Design outcomes

Primary

Measure	Time frame
To investigate the safety and tolerability of AZD1480	Safety and tolerability monitoring will proceed for whole study period. Screening, Cycle1Day1, Cycle1Day5 (only for Part B), Cycle1Day8, Cycle1Day15, Cycle2Day1, Cycle2Day8 and Day1 of further Cycles, IP discontinued visit and 30-days follow up

Secondary

Measure	Time frame
To evaluate the pharmacokinetics (PK) of AZD1480 following single dose and multiple doses	Part A and Expansion - 12 times during Cycle 1, 11 times during Cycle 2. Part B and C - 11 times during Cycle 1, 10 times during Cycle 2. *1 additional PK sample in Cycle 1 will be collect for optional biopsy sample collected patients.
To obtain a preliminary assessment of the anti-tumour activity of AZD1480	Tumour response assessment by RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 every 6 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026