MK-2461 Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Sponsored by industry investigator Merck Sharp & Dohme LLC, several clinical trials have evaluated the safety, pharmacokinetics, and therapeutic efficacy of the multi-kinase inhibitor MK-2461 in advanced cancer and malignant solid neoplasms. The trial portfolio comprises early-phase evaluations, including standalone Phase I dose-escalation protocols and combined Phase I/II proof-of-concept studies. Official records indicate that all listed trials in these advanced solid tumor populations have reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00518739	COMPLETED	Advanced Cancer	Merck Sharp & Dohme LLC	2007-02	PHASE1
NCT00496353	COMPLETED	Neoplasm	Merck Sharp & Dohme LLC	2007-06	PHASE1; PHASE2
NCT00496353	Completed	Neoplasm	Merck Sharp & Dohme LLC	2007-06	Phase 1\|Phase 2
NCT00518739	Completed	Advanced Cancer	Merck Sharp & Dohme LLC	2007-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2015-03-27)

Check the MK-2461 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-2461 selectively binds to activated receptor tyrosine kinases, primarily c-Met and its oncogenic mutants, which blocks intracellular phosphorylation of c-Met docking sites as well as downstream AKT and ERK1/2 signaling pathways to inhibit tumor cell proliferation. By suppressing these hyperactive oncogenic signaling cascades, MK-2461 prevents tumor expansion and demonstrates therapeutic potential for treating patients with advanced cancer and malignant solid 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>).