Lucanthone Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

A clinical trial evaluated the therapeutic application of lucanthone in combination with whole brain radiation therapy for patients presenting with brain metastases originating from non-small cell lung cancer. Sponsored by Wake Forest University Health Sciences in collaboration with Spectrum Pharmaceuticals Inc, this Phase 2 study was designed to assess the combination regimen in oncology patients. However, the trial's recruitment status is listed as withdrawn, summarizing the current clinical landscape for the compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02014545	Withdrawn	Brain Metastases\|Non-small Cell Lung Cancer	Wake Forest University Health Sciences\|Spectrum Pharmaceuticals Inc	2016-01	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lucanthone acts as a thioxanthone-based DNA intercalator and apurinic-apyrimidinic endonuclease 1 inhibitor while also suppressing autophagy, effectively disrupting DNA repair mechanism cascades and inducing tumor cell apoptosis. By compromising cellular resistance to DNA damage, lucanthone sensitizes cancer cells to therapeutic radiation, providing potential clinical utility in managing brain metastases secondary to non-small cell 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>).