SNS-314 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Several clinical trials sponsored by Sunesis Pharmaceuticals have evaluated the investigational Aurora kinase inhibitor SNS-314 in patients diagnosed with advanced solid tumors across multicenter settings. These completed early-phase studies investigated dose-escalation treatment regimens to establish the safety, tolerability, pharmacokinetic, and pharmacodynamic parameters of the compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00519662	COMPLETED	Advanced Solid Tumors	Sunesis Pharmaceuticals	2007-08	PHASE1
NCT00519662	Completed	Advanced Solid Tumors	Sunesis Pharmaceuticals	2007-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2017-04-04)

Check the SNS-314 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SNS-314 functions as an ATP-competitive inhibitor that selectively binds to Aurora kinases A, B, and C, thereby potently blocking downstream substrate phosphorylation such as Histone H3 phosphorylation. This inhibition disrupts mitotic spindle assembly and chromosome alignment, triggering cell cycle arrest and apoptosis to prevent cellular proliferation in advanced 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>).