Vadimezan (DMXAA) Clinical Trials

Size	Price	Qty
5mg	USD 147
10mg	USD 247

Clinical Trials

Multiple clinical trials have evaluated Vadimezan (DMXAA, ASA404) in Phase 1 and Phase 2 studies targeting solid tumors, non-small cell lung cancer, refractory malignancies, and metastatic prostate cancer. Sponsored by industry and academic entities—including Novartis, Antisoma, Cancer Research UK, and the Swiss Cancer Institute—these completed and terminated protocols investigated early-phase safety, dosing, and Phase 2 chemotherapy combinations. Collectively, these investigations assessed the compound as both a monotherapy and a combination partner for advanced malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01057342	COMPLETED	Lung Cancer	Swiss Cancer Institute	2010-01	PHASE2
NCT01278758	TERMINATED	Metastatic Cancer	Novartis Pharmaceuticals	2010-03	PHASE1
NCT01290380	TERMINATED	Solid Tumor Malignancies	Novartis Pharmaceuticals	2010-02	PHASE1
NCT01299415	TERMINATED	Solid Tumors	Novartis Pharmaceuticals	2009-08	PHASE1
NCT01285453	COMPLETED	Advanced or Recurrent Solid Tumors	Novartis Pharmaceuticals	2009-03	PHASE1
NCT00832494	COMPLETED	Non-Small Cell Lung Cancer	Antisoma Research	2004-09	PHASE1; PHASE2
NCT00111618	COMPLETED	Prostate Cancer	Antisoma Research	2005-05	PHASE2
NCT00856336	COMPLETED	Refractory Tumors	Antisoma Research	2003-05	PHASE1
NCT00856336	Completed	Refractory Tumors	Antisoma Research	2003-05	Phase 1
NCT00863733	COMPLETED	Solid Tumors	Cancer Research UK	1996-05	PHASE1
NCT00863733	Completed	Solid Tumors	Cancer Research UK\|Cancer Society Auckland	1996-05	Phase 1
NCT00003697	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	University of Glasgow	1995-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-04-10)

Check the Vadimezan (DMXAA) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vadimezan (DMXAA) acts as a STING agonist and tumor-vascular disrupting agent, triggering the release of type I interferons and vasoactive cytokines that disrupt tumor vascular endothelial cell function. This acute breakdown of established tumor blood vessels starves the neoplastic tissue of oxygen and nutrients, leading to tumor necrosis and regression in solid tumors, such as lung cancer and prostate 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>).