PLX51107 Clinical Trials

Size	Price	Qty
5mg	USD 237
25mg	USD 710

Clinical Trials

PLX51107 has been evaluated across several clinical trials investigating its potential as monotherapy and in combination regimens with azacitidine. These early-phase (Phase 1 and Phase 1/2) studies—sponsored by industry partner Plexxikon alongside academic sites like M.D. Anderson Cancer Center—targeted solid tumors, steroid-refractory acute graft-versus-host disease, acute myeloid leukemia, myelodysplastic syndromes, and non-Hodgkin lymphoma. Recorded outcomes reflect varying recruitment statuses across the clinical portfolio, with certain studies completed while others were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04910152	TERMINATED	Acute Graft Versus Host Disease; Steroid Refractory Graft Versus Host Disease	Hannah Choe, MD	2022-04-19	PHASE1; PHASE2
NCT04022785	COMPLETED	Acute Myeloid Leukemia; Myelodysplastic Syndrome; Myelodysplastic/Myeloproliferative Neoplasm; Myeloproliferative Neoplasm	M.D. Anderson Cancer Center	2019-09-09	PHASE1
NCT02683395	TERMINATED	Solid Tumors; Acute Myeloid Leukemia; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma	Plexxikon	2016-03	PHASE1
NCT02683395	Terminated	Solid Tumors\|Acute Myeloid Leukemia\|Myelodysplastic Syndrome\|Non-Hodgkin''s Lymphoma	Plexxikon	2016-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-01-28)

Check the PLX51107 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PLX51107 functions as a selective BET bromodomain inhibitor that preferentially binds to the BD1 domain of BRD2, BRD3, BRD4, and BRDT, thereby disrupting bromodomain interaction with acetylated chromatin and suppressing downstream oncogenic gene transcription. This transcriptional inhibition arrests cell cycle progression and promotes apoptosis, thereby curtailing pathological cell growth in clinical conditions such as acute myeloid leukemia, myelodysplastic syndrome, solid tumors, and acute graft-versus-host disease.

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>).