Clinical Trials

A clinical trial sponsored by Memorial Sloan Kettering Cancer Center is evaluating Meclofenamate Sodium in subjects with recurrent or progressive brain metastases originating from solid primary tumors. This active, non-recruiting pilot study lacks a standard numerical phase designation, focusing on safety and early therapeutic signals in secondary central nervous system malignancies. Overall, clinical evaluation of this compound remains focused on advanced brain metastases within academic institutional research.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02429570 ACTIVE_NOT_RECRUITING
Recurrent Brain Metastases; Progressive Brain Metastases
Memorial Sloan Kettering Cancer Center
2015-04-22

(data from https://clinicaltrials.gov, updated on 2026-05-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Meclofenamate Sodium acts as a dual cyclooxygenase-1 and cyclooxygenase-2 inhibitor with additional gap-junction and fat mass and obesity-associated enzyme blocking capabilities, which effectively prevents downstream eicosanoid biosynthesis and intercellular signal transmission. By suppressing inflammatory prostaglandin pathways and microenvironmental intercellular communication, this inhibition limits tumor survival mechanisms, demonstrating direct clinical relevance to the treatment of recurrent or progressive brain metastases.

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>).

Note: Technical data last updated: Sep 1, 2026.