Belotecan (CKD-602) hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 457

Clinical Trials

Belotecan (CKD-602) has been evaluated across several clinical trials investigating its safety, pharmacokinetics, and therapeutic efficacy in small cell lung cancer, non-small cell lung carcinoma, uterine cervical cancer, epithelial ovarian cancer, and refractory solid malignancies. Encompassing Phase 1 dose-escalation, Phase 2 efficacy, and Phase 3 comparative studies, these trials were sponsored by academic medical centers and pharmaceutical developers such as Chong Kun Dang Pharmaceutical. The majority of these recorded trials have reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01784107	UNKNOWN	Small Cell Lung Cancer	Gachon University Gil Medical Center	2011-07	PHASE1; PHASE2
NCT01497873	COMPLETED	Small Cell Lung Cancer	Chong Kun Dang Pharmaceutical	2010-09	PHASE2
NCT01630018	COMPLETED	Epithelial Ovarian Cancer	Chong Kun Dang Pharmaceutical	2011-01	PHASE2
NCT00826644	COMPLETED	Carcinoma, Small Cell	Chonnam National University Hospital	2009-01	PHASE3
NCT00754858	COMPLETED	Lung Cancer	Yonsei University	2008-10	PHASE2
NCT01022671	COMPLETED	Carcinoma, Non-Small-Cell Lung	Chong Kun Dang Pharmaceutical	2009-09	PHASE2
NCT00430144	COMPLETED	Cervical Cancer	Sokbom Kang	2007-01	PHASE2
NCT00177281	COMPLETED	Cancer	University of Pittsburgh	2003-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2016-02-10)

Check the Belotecan (CKD-602) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Belotecan selectively binds to and stabilizes the topoisomerase I-DNA cleavage complex, preventing the re-ligation of single-stranded DNA breaks and inducing lethal double-stranded DNA damage during active replication. This accumulation of unrepaired DNA breakage halts replication fork progression and triggers apoptotic cell death, thereby suppressing tumor growth in topoisomerase I-dependent malignancies such as small cell lung cancer and ovarian 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>).