Numerous early-phase clinical trials, encompassing Phase 1, Phase 2, and combined Phase 1/2 studies, have evaluated the CXCR2 antagonist AZD5069 across respiratory inflammatory diseases and oncology indications. These investigations evaluated the compound in chronic obstructive pulmonary disease, persistent asthma, bronchiectasis, metastatic castration-resistant prostate cancer, and advanced solid tumors, including head and neck squamous cell carcinoma. Sponsored by pharmaceutical entities and research institutions, these completed and terminated studies reflect a clinical development strategy aimed at dampening pathological immune responses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03177187 | TERMINATED | Metastatic Castration Resistant Prostate Cancer |
Institute of Cancer Research, United Kingdom |
2017-11-13 | PHASE1; PHASE2 |
| NCT02499328 | COMPLETED | Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck |
AstraZeneca |
2015-08-06 | PHASE1; PHASE2 |
| NCT02583477 | COMPLETED | Metastatic Pancreatic Ductal Adenocarcinoma |
AstraZeneca |
2016-03-25 | PHASE1; PHASE2 |
| NCT03177187 | Terminated | Metastatic Castration Resistant Prostate Cancer |
Institute of Cancer Research United Kingdom|Astellas Pharma Inc|AstraZeneca|Prostate Cancer UK |
2017-11-13 | Phase 1|Phase 2 |
| NCT01704495 | COMPLETED | Asthma |
AstraZeneca |
2012-11 | PHASE2 |
| NCT01890148 | COMPLETED | Asthma |
AstraZeneca |
2014-03 | PHASE1 |
| NCT01962935 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD). |
AstraZeneca |
2013-11 | PHASE1 |
| NCT01989520 | COMPLETED | Uncontrolled and Persistent Asthma |
AstraZeneca |
2014-01 | PHASE1 |
| NCT01962935 | Completed | Chronic Obstructive Pulmonary Disease (COPD). |
AstraZeneca |
2013-11 | Phase 1 |
| NCT01735240 | COMPLETED | Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite |
AstraZeneca |
2012-12 | PHASE1 |
| NCT01735240 | Completed | Asthma|Pharmacokinetics|Cmax|Tmax|λz|AUC|Ketoconazole|Metabolite |
AstraZeneca |
2012-12 | Phase 1 |
| NCT01480739 | COMPLETED | Chemokine Receptor 2 (CXCR2) Antagonist |
AstraZeneca |
2011-12 | PHASE1 |
| NCT01255592 | COMPLETED | Bronchiectasis; Lung Disease; Respiratory Diseases |
AstraZeneca |
2011-02 | PHASE2 |
| NCT01332903 | COMPLETED | Healthy |
AstraZeneca |
2011-05 | PHASE1 |
| NCT01233232 | COMPLETED | Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD); Laymen Terminology Chronic Bronchitis and Emphysema |
AstraZeneca |
2010-11 | PHASE2 |
| NCT01100047 | COMPLETED | Healthy |
AstraZeneca |
2010-05 | PHASE1 |
| NCT01083238 | COMPLETED | Chronic Obstructive Pulmonary Disease |
AstraZeneca |
2010-02 | PHASE1 |
| NCT01051505 | COMPLETED | Healthy |
AstraZeneca |
2010-01 | PHASE1 |
| NCT00953888 | COMPLETED | Healthy |
AstraZeneca |
2009-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2024-09-26)
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>).