BAY 1217389 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Bayer have evaluated the therapeutic potential of the selective kinase inhibitor BAY 1217389 in oncology populations. These early-phase studies characterized the safety, tolerability, pharmacokinetics, and maximum tolerated dose of the agent, and all of these trials have reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02366949	COMPLETED	Medical Oncology	Bayer	2015-02-27	PHASE1
NCT02366949	Completed	Medical Oncology	Bayer	2015-02-27	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-04-07)

Check the BAY 1217389 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAY 1217389 selectively binds to and inhibits monopolar spindle 1 kinase, which disrupts spindle assembly checkpoint signaling and impairs proper chromosome alignment during mitosis. This persistent checkpoint inhibition induces aberrant chromosomal segregation and mitotic catastrophe, resulting in apoptotic cell death in proliferating tumor cells and underpinning its therapeutic investigation in medical oncology.

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>).