GSK-2879552 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

GlaxoSmithKline has sponsored multiple clinical trials evaluating GSK-2879552 in patients with hematologic malignancies and solid tumors, specifically small cell carcinoma, acute myelocytic leukaemia, and myelodysplastic syndromes. These early-phase evaluations included Phase I open-label trials and a Phase I/II investigation to assess safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. Across all trials, the recruitment status for this investigational agent is currently listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02929498	TERMINATED	Myelodysplastic Syndrome; Myelodysplastic Syndromes	GlaxoSmithKline	2017-07-31	PHASE1; PHASE2
NCT02177812	TERMINATED	Leukaemia, Myelocytic, Acute	GlaxoSmithKline	2014-08-27	PHASE1
NCT02034123	TERMINATED	Carcinoma, Small Cell	GlaxoSmithKline	2014-02-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2019-05-14)

Check the GSK-2879552 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK-2879552 acts as a potent and selective inhibitor of lysine-specific demethylase 1 (LSD1/KDM1A), binding the enzyme to prevent demethylation of histone H3 lysine 4 residues and induce the expression of silenced target genes. This transcriptional reactivation triggers cytostatic antiproliferative activity, suppressing cellular growth in therapeutic settings such as small cell lung carcinoma, acute myelocytic leukaemia, and myelodysplastic syndromes.

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>).