Clinical Trials

AZD1480 has been evaluated across several clinical trials sponsored exclusively by AstraZeneca, focusing primarily on Phase 1 evaluations of safety, tolerability, and pharmacokinetics. These investigations targeted advanced solid malignancies—including gastric cancer, hepatocellular carcinoma, lung metastatic carcinoma, and EGFR- or ROS-mutant non-small cell lung cancer—alongside myeloproliferative neoplasms such as primary, post-polycythemia vera, and essential thrombocythemia myelofibrosis. While certain trials in myelofibrosis reached completion, other studies evaluating solid tumors were terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01219543 TERMINATED
Solid Tumour; Advanced Solid Malignancies; Child-Pugh A to B7 Advanced Hepatocellular Carcinoma; EGFR and/or ROS Mutant NSCLC; Lung Metastasis Carcinoma; Gastric Cancer
AstraZeneca
2010-11 PHASE1
NCT01112397 TERMINATED
Solid Malignancies
AstraZeneca
2010-04 PHASE1
NCT00910728 COMPLETED
Primary Myelofibrosis (PMF); Post-Polycythaemia Vera; Essential Thrombocythaemia Myelofibrosis
AstraZeneca
2009-05 PHASE1
NCT01219543 Terminated
Solid Tumour|Advanced Solid Malignancies|Child-Pugh A to B7 Advanced Hepatocellular Carcinoma|EGFR and/or ROS Mutant NSCLC|Lung Metastasis Carcinoma|Gastric Cancer
AstraZeneca
2010-11 Phase 1
NCT01112397 Terminated
Solid Malignancies
AstraZeneca
2010-04 Phase 1

(data from https://clinicaltrials.gov, updated on 2013-01-08)

Check the AZD1480 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1480 functions as a potent ATP-competitive inhibitor of Janus kinase 2 (JAK2), effectively preventing the phosphorylation of STAT5 and blocking STAT3 nuclear translocation. This biochemical blockade suppresses cancer cell proliferation and inhibits tumorigenesis, providing therapeutic rationale for its clinical investigation in advanced solid malignancies and myeloproliferative disorders like primary myelofibrosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.