AZD5438 Clinical Trials

Size	Price	Qty
10mg	USD 150
50mg	USD 570

Clinical Trials

The clinical trial landscape for AZD5438 includes a clinical trial evaluating the compound's safety, tolerability, and clinical profile in patients with advanced solid neoplasms. Sponsored by AstraZeneca, this completed Phase I study represents the primary investigation assessing human tolerance to the drug in malignant disease settings. Consequently, clinical development of AZD5438 remains centered on early-phase evaluation for advanced tumor conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00088790	COMPLETED	Neoplasms	AstraZeneca	2004-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2011-01-26)

Check the AZD5438 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD5438 binds to and inhibits cyclin-dependent kinases 1, 2, and 9, thereby blocking the downstream phosphorylation of critical substrate proteins including retinoblastoma protein and RNA polymerase II. This inhibition halts cell cycle progression at the G1, S, and G2-M phases to suppress tumor cell proliferation, underlying its therapeutic relevance in clinical trials for advanced solid neoplasms.

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>).