9-amino-CPT (9-Aminocamptothecin) Clinical Trials

Size	Price	Qty
5mg	USD 177

Clinical Trials

Multiple clinical trials evaluate 9-amino-CPT across oncology—specifically non-small cell lung cancer, refractory lymphomas, acute myelocytic leukemia, acute lymphocytic leukemia, and bladder cancer—as well as dyslipidemias. These Phase 1, Phase 2, and unassigned evaluations span completed, active but not recruiting, and unknown recruitment statuses. Sponsoring organizations include government entities such as the National Cancer Institute, major academic medical centers like Dana-Farber Cancer Institute and Case Comprehensive Cancer Center, and industry partners.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04909489	Unknown status	Traditional Chinese Medicine\|Dyslipidemias\|Syndrome	Dongzhimen Hospital Beijing	2021-04-21	--
NCT03978624	Active not recruiting	Bladder Cancer	UNC Lineberger Comprehensive Cancer Center\|Merck Sharp & Dohme LLC\|Syndax Pharmaceuticals	2020-09-23	Phase 2
NCT00003154	Completed	Lung Cancer	Case Comprehensive Cancer Center\|National Cancer Institute (NCI)	1998-01	Phase 2
NCT00002745	Completed	Lymphoma	National Cancer Institute (NCI)	1996-04	Phase 2
NCT00251368	Completed	Leukemia Myelocytic Acute\|Acute Lymphocytic Leukemia	Dana-Farber Cancer Institute\|Brigham and Women''s Hospital\|Beth Israel Deaconess Medical Center\|Massachusetts General Hospital	1995-01	Phase 1

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

Check the 9-amino-CPT (9-Aminocamptothecin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

9-amino-CPT selectively binds to and stabilizes the topoisomerase I-DNA cleavage complex, preventing the religation of single-stranded DNA breaks during transcription and replication. This persistence of DNA strand breakage induces irreversible double-strand breaks and activates apoptotic pathways, thereby suppressing tumor cell proliferation in clinical indications such as lung cancer, lymphoma, and acute leukemia.

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>).