CX-3543(Quarfloxin) Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Sponsored by Cylene Pharmaceuticals, the clinical development of CX-3543 (Quarfloxin) encompasses several clinical trials across Phase I and Phase II evaluations. Phase I studies assessed safety, tolerability, and pharmacokinetics in patients with advanced solid malignancies and lymphomas, resulting in both completed and terminated trials. Subsequent Phase II research included a completed clinical trial evaluating therapeutic efficacy in low-to-intermediate grade neuroendocrine and carcinoid tumors, as well as a clinical trial in B-cell chronic lymphocytic leukemia that was withdrawn prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00780663	COMPLETED	Neuroendocrine Tumors; Carcinoid Tumor	Cylene Pharmaceuticals	2008-10	PHASE2
NCT00955292	TERMINATED	Advanced Solid Tumors; Lymphoma	Cylene Pharmaceuticals	2007-07	PHASE1
NCT00955786	COMPLETED	Advanced Solid Tumors; Lymphoma	Cylene Pharmaceuticals	2005-07	PHASE1
NCT00485966	WITHDRAWN	B-Cell Chronic Lymphocytic Leukemia	Cylene Pharmaceuticals	2007-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2011-06-15)

Check the CX-3543(Quarfloxin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CX-3543 selectively disrupts nucleolin and ribosomal DNA G-quadruplex complexes within the nucleolus, thereby inhibiting RNA polymerase I activity and blocking downstream ribosomal RNA synthesis. This targeted transcriptional disruption triggers nucleolar stress and induces apoptosis in neoplastic cells, providing the biological rationale for its therapeutic evaluation in neuroendocrine tumors, lymphomas, and advanced solid malignancies.

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>).