Beta-Lapachone Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials across Phase I, Phase I/II, and Phase II have evaluated Beta-Lapachone (also known as ARQ 501 and ARQ 761) for oncology indications, including advanced solid tumors, squamous cell carcinoma of the head and neck, and metastatic pancreatic adenocarcinoma. Sponsored by both industry entities, such as ArQule Inc., and academic medical centers, including the University of Texas Southwestern Medical Center, these trials are predominantly completed, although a clinical trial was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02514031	TERMINATED	Pancreatic Cancer	University of Texas Southwestern Medical Center	2016-03-24	PHASE1
NCT01502800	COMPLETED	Solid Tumors	University of Texas Southwestern Medical Center	2011-12-29	PHASE1
NCT00524524	Completed	Advanced Solid Tumors	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2007-08	Phase 1
NCT00622063	Completed	Cancer	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2006-12	Phase 1\|Phase 2
NCT00358930	Completed	Head and Neck Neoplasms\|Carcinoma Squamous Cell	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2006-07	Phase 2
NCT00102700	Completed	Pancreatic Cancer\|Adenocarcinoma	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2005-01	Phase 2
NCT00099190	Completed	Carcinoma	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2004-12	Phase 1

(data from https://clinicaltrials.gov, updated on 2022-06-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Beta-Lapachone acts as a selective inhibitor of DNA topoisomerase I without inhibiting DNA topoisomerase II or ligase, thereby blocking DNA unwinding during replication and inducing double-strand DNA damage that leads to apoptotic cell death. By destabilizing genomic integrity in actively dividing cells, this mechanism provides therapeutic relevance for clinical applications in advanced solid tumors, pancreatic adenocarcinoma, and head and neck carcinomas.

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>).