ARRY-382 Clinical Trials

Size	Price	Qty
5mg	USD 559
25mg	USD 1,677

Clinical Trials

A Phase 1/Phase 2 industry-sponsored clinical trial evaluated the therapeutic potential of ARRY-382 in combination with pembrolizumab for advanced solid tumors. Initiated by Pfizer to assess preliminary safety and efficacy profiles, the study's recruitment status was ultimately listed as terminated. Consequently, clinical evidence for this targeted compound remains restricted to early-phase investigation within solid tumor oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02880371	Terminated	Advanced Solid Tumors	Pfizer	2016-09-01	Phase 1\|Phase 2

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

Check the ARRY-382 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ARRY-382 is a potent, oral, and highly selective inhibitor of CSF1R (c-Fms tyrosine kinase) with an IC50 of 9 nM that binds the receptor kinase domain to block downstream autophosphorylation and intracellular signaling cascades. By suppressing CSF1R activity, the compound reduces tumor-associated macrophage survival and recruitment within the microenvironment, thereby reversing local immunosuppression to inhibit tumor growth in advanced solid tumors.

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>).