Ammonium tetrathiomolybdate Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

In oncology, a clinical trial evaluated the anti-angiogenic copper chelator ammonium tetrathiomolybdate in combination with radiotherapy for patients with stage I to IIIB non-small cell lung cancer. Sponsored by the Roswell Park Cancer Institute, this Phase I study aimed to assess the safety and efficacy of the combined regimen, though its recruitment status was ultimately listed as withdrawn. Consequently, clinical research on this compound remains limited to early-phase exploratory evaluation in pulmonary malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00560495	WITHDRAWN	Lung Cancer	Roswell Park Cancer Institute	2007-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2022-10-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ammonium tetrathiomolybdate acts primarily as a potent copper chelator that selectively sequesters bioavailable copper ions, thereby impairing copper-dependent signaling pathways essential for endothelial cell proliferation and pro-angiogenic factor activity. By suppressing downstream vascularization and tumor nutrient supply, this mechanism provides the biological rationale for its clinical evaluation in lung cancer.

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>).