AZD1152(Barasertib) Clinical Trials

Size	Price	Qty
5mg	USD 150

Clinical Trials

AZD1152 (Barasertib) has been evaluated across several clinical trials spanning Phase 1, Phase 2, and Phase 3 to assess its safety, pharmacokinetics, and efficacy in acute myeloid leukemia, diffuse large B-cell lymphoma, and advanced solid tumors. Sponsored by AstraZeneca alongside academic partners including Oxford University Hospitals NHS Trust, these studies evaluated the drug as monotherapy or combination therapy. While initial Phase 1 studies in solid tumors were terminated, multiple clinical trials targeting acute myeloid leukemia and lymphoma successfully reached completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01354392	COMPLETED	Lymphoma	Oxford University Hospitals NHS Trust	2011-09	PHASE1; PHASE2
NCT00952588	COMPLETED	Acute Myeloid Leukemia	AstraZeneca	2009-07	PHASE2; PHASE3
NCT00926731	COMPLETED	Acute Myeloid Leukemia	AstraZeneca	2009-06	PHASE1
NCT01019161	COMPLETED	Acute Myeloid Leukaemia	AstraZeneca	2009-11	PHASE1
NCT00497991	COMPLETED	Myeloid Leukemia	AstraZeneca	2006-05	PHASE1
NCT00530699	COMPLETED	Acute Myeloid Leukaemia	AstraZeneca	2007-11	PHASE1
NCT00338182	COMPLETED	Tumors	AstraZeneca	2006-05-23	PHASE1
NCT00497731	TERMINATED	Solid Tumors	AstraZeneca	2005-05	PHASE1
NCT00497679	TERMINATED	Solid Tumours	AstraZeneca	2006-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-07-02)

Check the AZD1152(Barasertib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1152 selectively binds to and inhibits Aurora B kinase, converting rapidly in plasma to its active metabolite AZD1152-HQPA to disrupt chromosome alignment during mitosis and trigger apoptotic cell death in proliferating populations. This targeted suppression of mitotic division provides the biochemical rationale for its clinical evaluation in acute myeloid leukemia, lymphoma, and solid tumors.

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>).