Refametinib (RDEA119) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase I, I/II, and II clinical trials evaluate the therapeutic potential and pharmacological profile of refametinib as monotherapy and in combination regimens. Sponsored primarily by industry entities like Bayer alongside academic centers such as Samsung Medical Center, these investigations target advanced cancer, hepatocellular carcinoma, biliary tract cancer, broad solid neoplasms, and drug interactions. Although the majority of these studies are completed, select combination trials were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02346032	COMPLETED	Biliary Tract Cancer	Samsung Medical Center	2015-06-30	PHASE2
NCT02168777	TERMINATED	Neoplasms	Bayer	2014-06-23	PHASE1
NCT01915602	COMPLETED	Carcinoma, Hepatocellular	Bayer	2013-09-27	PHASE2
NCT01764828	COMPLETED	Neoplasms	Bayer	2013-02-05	PHASE1
NCT01915589	COMPLETED	Carcinoma, Hepatocellular	Bayer	2013-09-16	PHASE2
NCT01392521	COMPLETED	Neoplasms	Bayer	2011-07	PHASE1
NCT01925638	COMPLETED	Drug Interactions	Bayer	2013-09	PHASE1
NCT00785226	COMPLETED	Advanced Cancer	Bayer	2008-11	PHASE1; PHASE2
NCT01392521	Completed	Neoplasms	Bayer	2011-07	Phase 1
NCT00610194	COMPLETED	Advanced Cancer	Bayer	2007-11-28	PHASE1
NCT00785226	Completed	Advanced Cancer	Bayer	2008-11	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2017-04-26)

Check the Refametinib (RDEA119) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Refametinib is an ATP non-competitive inhibitor that selectively binds to mitogen-activated protein kinase kinase 1 and 2 (MEK1/2), thereby suppressing downstream phosphorylation of extracellular signal-regulated kinase (ERK) within the hyperactive RAS/RAF/MEK/ERK signaling cascade. This target blockade inhibits essential cell survival and proliferation pathways, ultimately driving tumor growth inhibition and therapeutic response in advanced solid tumors, including hepatocellular carcinoma and biliary tract 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>).