(S)-10-Hydroxycamptothecin Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 297

Clinical Trials

Multiple clinical trials evaluate topoisomerase I inhibitors and related formulations to assess safety, pharmacokinetics, and efficacy across indications including advanced solid tumors, small cell lung cancer, extra-pulmonary small cell carcinomas, first-line metastatic colorectal cancer, and lymphoma. Encompassing Phase 1, Phase 1/2, and Phase 2 designs, these studies are sponsored by industry and academic institutions—including TaiRx Inc., Enzon Pharmaceuticals Inc., Centre Jean Perrin, and the National Cancer Institute—with recruitment statuses ranging from recruiting and active not recruiting to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06143774	Recruiting	Advanced Solid Tumor	TaiRx Inc.	2023-10-31	Phase 1
NCT04209595	Active not recruiting	Small Cell Lung Cancer\|Extra-Pulmonary Small Cell Carcinomas	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2020-04-08	Phase 1\|Phase 2
NCT01963182	Completed	First Line Metastatic Colorectal Cancer	Centre Jean Perrin	2013-10	Phase 2
NCT00520390	Completed	Lymphoma\|Advanced Solid Tumors	Enzon Pharmaceuticals Inc.	2007-05	Phase 1
NCT00520637	Completed	Advanced Solid Tumors\|Lymphoma	Enzon Pharmaceuticals Inc.	2007-05	Phase 1

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

Check the (S)-10-Hydroxycamptothecin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(S)-10-Hydroxycamptothecin functions as a potent inhibitor of DNA topoisomerase I by stabilizing persistent cleavable complexes, which promotes replication fork collisions, lethal DNA lesions, G2 cell cycle arrest, and caspase-3-dependent apoptosis. By suppressing endothelial cell angiogenesis and tumor cell proliferation, this mechanistic blockade underpins its therapeutic rationale in clinical trials for advanced solid tumors, metastatic colorectal cancer, lymphoma, and small cell lung 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>).