MK-5108 Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 970

Clinical Trials

Clinical evaluation of MK-5108 in oncology has focused on early-stage research for patients diagnosed with advanced solid tumors, neoplasms, and malignant cancers. In a completed Phase 1 study sponsored by Merck Sharp & Dohme LLC, researchers evaluated the safety, tolerability, and dosing parameters of MK-5108 both as a single agent and in combination with docetaxel. This initial trial aimed to establish the safety profile and preliminary therapeutic utility of targeting mitotic kinase pathways in human malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00543387	COMPLETED	Cancer, Neoplasms, Tumors	Merck Sharp & Dohme LLC	2008-03-27	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-06-05)

Check the MK-5108 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-5108 functions as a potent, ATP-competitive inhibitor that selectively binds Aurora A kinase, blocking its enzymatic activity and preventing proper mitotic spindle assembly during cell division. This molecular disruption triggers cell cycle arrest at the G2/M transition and induces apoptotic signaling pathways, ultimately suppressing tumor cell proliferation in advanced solid tumors and neoplasms.

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>).