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)
Mechanism and Biochemical Profile
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>).