Atorvastatin Calcium (CI-981) Clinical Trials

Size	Price	Qty
50mg	USD 147
500mg	USD 770

Clinical Trials

A clinical trial evaluated Atorvastatin Calcium for oncology indications, specifically investigating its application in recurrent and stages I through IV prostate cancer. Collaboratively sponsored by an academic institution, the University of Nebraska, and a government agency, the National Cancer Institute, the study was designated as Phase Not Applicable. However, the trial's recruitment status is marked as withdrawn, indicating that patient enrollment was discontinued prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01555632	Withdrawn	Recurrent Prostate Cancer\|Stage I Prostate Cancer\|Stage IIA Prostate Cancer\|Stage IIB Prostate Cancer\|Stage III Prostate Cancer\|Stage IV Prostate Cancer	University of Nebraska\|National Cancer Institute (NCI)	2012-03	Not Applicable

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

Check the Atorvastatin Calcium (CI-981) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atorvastatin Calcium competitively binds to and inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, blocking the rate-limiting conversion of HMG-CoA to mevalonate and disrupting downstream cholesterol biosynthesis. This metabolic blockade induces apoptotic cell death and autophagy, providing a mechanistic rationale for evaluating its therapeutic potential in limiting tumor proliferation across various stages of prostate 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>).