Trametinib DMSO solvate (GSK1120212B) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Multiple clinical trials evaluate the therapeutic application of trametinib across oncology and vascular conditions, including BRAF V600-mutated solid tumors, KRAS-mutated cholangiocarcinoma, and arteriovenous malformations. Encompassing Phase 1, Phase 1/2, and Phase 2 protocols, these studies are sponsored by entities including Xynomic Pharmaceuticals, University Health Network Toronto, Erasca, and Genfit. Currently spanning both recruiting and not-yet-recruiting statuses, these trials investigate single-agent and combination treatment strategies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05275374	Not yet recruiting	Cancer\|BRAF V600 Mutation\|Melanoma\|Colorectal Cancer\|Thyroid Cancer\|Nonsmall Cell Lung Cancer	Xynomic Pharmaceuticals Inc.	2024-12	Phase 1\|Phase 2
NCT06098872	Not yet recruiting	Arteriovenous Malformations	University Health Network Toronto	2023-11	Phase 2
NCT05907304	Recruiting	Advanced or Metastatic Solid Tumors	Erasca Inc.	2023-08-17	Phase 1
NCT05874414	Recruiting	Cholangiocarcinoma	Genfit	2023-08-21	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Trametinib DMSO solvate (GSK1120212B) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trametinib selectively binds to MEK1 and MEK2 enzymes, suppressing downstream MAPK/ERK pathway signaling to activate autophagy and induce apoptosis in targeted cells. By inhibiting MEK-driven kinase activity, this molecular cascade blocks tumor cell survival and proliferation, demonstrating therapeutic relevance in clinical conditions such as BRAF-mutated solid tumors, melanoma, lung cancer, and cholangiocarcinoma.

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>).