MK-8353 (SCH900353) Clinical Trials

Size	Price	Qty
2mg	USD 170
5mg	USD 327

Clinical Trials

Multiple clinical trials sponsored by Merck Sharp & Dohme LLC have evaluated MK-8353 (SCH900353) across Phase 1 and Phase 1b oncology settings, predominantly in patients with advanced or metastatic solid tumors, neoplasms, and colorectal cancer. These early-phase evaluations investigated the candidate both as a monotherapy and in combination regimens with selumetinib or pembrolizumab. While a Phase 1b combination study with selumetinib was completed, other Phase 1 evaluations were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02972034	TERMINATED	Neoplasms; Colorectal Cancer	Merck Sharp & Dohme LLC	2017-01-13	PHASE1
NCT03745989	COMPLETED	Solid Tumors	Merck Sharp & Dohme LLC	2019-02-22	PHASE1
NCT03745989	Completed	Solid Tumors	Merck Sharp & Dohme LLC	2019-02-22	Phase 1
NCT01358331	TERMINATED	Tumor, Solid	Merck Sharp & Dohme LLC	2011-11-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-11-21)

Check the MK-8353 (SCH900353) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-8353 is an orally bioavailable inhibitor that selectively binds to and inhibits extracellular signal-regulated kinases 1 and 2 (ERK1/2), thereby blocking downstream substrate phosphorylation in the MAPK/ERK pathway and inhibiting cancer cell proliferation. By suppressing hyperactivated MAPK pathway signaling, MK-8353 aims to halt tumor growth and progression in patients with advanced solid tumors and colorectal cancer.

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>).