Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Compound development discontinued
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
| Child-Pugh A to B7 Advanced Hepatocellular Carcinoma | — | UNRESOLVED | — |
| EGFR and/or ROS Mutant NSCLC | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lung Metastasis Carcinoma | — | UNRESOLVED | — |
| Solid Tumour | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD1480 BID | Drug | JAK2 Inhibitor AZD1480 | ALIAS |
| AZD1480 Daily | Drug | JAK2 Inhibitor AZD1480 | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part A
- description
- Daily dosing of AZD1480 to the patients with solid tumours excluding HCC
- interventionNames
- Drug: AZD1480 Daily
- type
- EXPERIMENTAL
- label
- Part B
- description
- BID dosing of AZD1480 to the patients with advanced HCC (Child-Pugh A to B7)
- interventionNames
- Drug: AZD1480 BID
- type
- EXPERIMENTAL
- label
- Part C
- description
- BID dosing of AZD1480 to the patients with solid tumours excluding HCC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available