Barasertib-HQPA (AZD2811) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

Multiple clinical trials sponsored by AstraZeneca have completed recruitment for Barasertib-HQPA (AZD2811 / AZD1152). These Phase 1 studies evaluated the safety, tolerability, pharmacokinetics, and metabolic pathways of the small molecule in patients presenting with advanced solid tumors and acute myeloid leukemia. Overall, these early-phase evaluations established fundamental clinical data regarding the compound's disposition and safety profile in human subjects with solid and hematological malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02579226	Completed	Advanced Solid Tumours	AstraZeneca	2015-10-28	Phase 1
NCT01019161	COMPLETED	Acute Myeloid Leukaemia	AstraZeneca	2009-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Barasertib-HQPA (AZD2811) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Barasertib-HQPA selectively binds to and inhibits Aurora B kinase, disrupting chromosome alignment and mitotic spindle assembly to halt cell division and trigger apoptosis in proliferating cells. By suppressing Aurora B-mediated cell cycle progression, this mechanism inhibits tumor proliferation, providing therapeutic relevance for the treatment of advanced solid tumors and acute myeloid leukemia.

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>).