CarboxyaMidotriazole orotate Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 687

Clinical Trials

Several clinical trials have evaluated carboxyamidotriazole orotate as a single agent or in combination with bevacizumab or lomustine across Phase 1 studies targeting advanced solid tumors, glioblastoma, and World Health Organization Grade III or IV recurrent malignant gliomas. These trials include investigator-initiated research led by Annick Desjardins alongside industry sponsorship from Tactical Therapeutics, Inc. Recruitment records indicate that multiple clinical trials were terminated, while the status of a clinical trial remains unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01107522	UNKNOWN	Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas	Tactical Therapeutics, Inc.	2010-05	PHASE1
NCT01954030	TERMINATED	Malignant Glioma (WHO Grade III or IV)	Annick Desjardins	2013-10	PHASE1
NCT01989052	TERMINATED	Malignant Glioma (WHO Grade III or IV)	Annick Desjardins	2014-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-09)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carboxyamidotriazole orotate functions by inhibiting nonvoltage-operated calcium channels, thereby disrupting intracellular calcium influx and blocking calcium-dependent signal transduction cascades necessary for tumor cell survival. This inhibition impairs cell motility, invasion, and tumor-associated angiogenesis, rendering the agent relevant for suppressing disease progression in solid tumors, glioblastoma, and recurrent malignant gliomas.

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>).