AZD1208 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Sponsored exclusively by AstraZeneca, several Phase 1 clinical trials evaluated AZD1208 to assess its safety, tolerability, pharmacokinetics, and preliminary therapeutic efficacy across hematologic malignancies and solid tumors. These investigations targeted acute myeloid leukemia, advanced solid malignancies, and malignant lymphoma, with study efforts completed for solid tumors and lymphoma but terminated for acute myeloid leukemia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01588548	COMPLETED	Advanced Solid Malignancies; Malignant Lymphoma	AstraZeneca	2012-07	PHASE1
NCT01489722	TERMINATED	Acute Myeloid Leukemia	AstraZeneca	2012-02	PHASE1
NCT01489722	Terminated	Acute Myeloid Leukemia	AstraZeneca	2012-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2015-11-04)

Check the AZD1208 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1208 acts as a potent inhibitor that selectively binds to Pim kinase isoforms Pim1, Pim2, and Pim3, thereby blocking downstream oncogenic signaling cascades essential for cell survival. This enzymatic blockade induces cell cycle arrest, autophagy, and apoptosis, which directly accounts for its potential therapeutic efficacy evaluated in clinical trials targeting acute myeloid leukemia, malignant lymphoma, and advanced solid malignancies.

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>).