AZD3514 Clinical Trials

Size	Price	Qty
50mg	USD 470

Clinical Trials

Multiple Phase 1 clinical trials sponsored by AstraZeneca have evaluated the therapeutic and pharmacological profile of AZD3514 in patients with prostate cancer. These completed, open-label, dose-escalation studies investigated the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the compound. Overall, these early-phase trials provide essential safety and clinical activity data in androgen receptor-driven malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01351688	COMPLETED	Prostate Cancer	AstraZeneca	2011-08	PHASE1
NCT01162395	COMPLETED	Prostate Cancer	AstraZeneca	2010-08	PHASE1
NCT01351688	Completed	Prostate Cancer	AstraZeneca	2011-08	Phase 1
NCT01162395	Completed	Prostate Cancer	AstraZeneca	2010-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2013-07-03)

Check the AZD3514 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD3514 directly binds to the androgen receptor with a Ki of 2.2 μM, promoting receptor downregulation and disrupting downstream transcriptional signaling required for androgen-dependent gene expression. This blockade of androgen receptor signaling inhibits cellular proliferation and tumor cell growth, highlighting its therapeutic potential in prostate cancer clinical trials.

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>).