AZD8186 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials have evaluated the safety, tolerability, and efficacy of AZD8186 as both monotherapy and in combination with chemotherapeutic agents such as paclitaxel or docetaxel. These studies focus on patients with advanced solid tumors, including castrate-resistant prostate, stomach, squamous non-small cell lung, and triple-negative breast cancers. Sponsored by pharmaceutical and academic organizations such as AstraZeneca, the National Cancer Institute, and Seoul National University Bundang Hospital, recruitment statuses across these trials range from unknown to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03218826	COMPLETED	Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Prostate Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Castration-Resistant Prostate Carcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Prostate Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Triple-Negative Breast Carcinoma; Unresectable Solid Neoplasm	National Cancer Institute (NCI)	2018-09-24	PHASE1
NCT04001569	UNKNOWN	Solid Tumor; Stomach Cancer	Seoul National University Bundang Hospital	2019-05-14	PHASE1; PHASE2
NCT01884285	COMPLETED	Advanced Castrate-resistant Prostate Cancer CRPC; Squamous Non-Small Cell Lung Cancer sqNSCLC; Triple Negative Breast Cancer TNBC	AstraZeneca	2013-07-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-29)

Check the AZD8186 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD8186 selectively binds to and inhibits phosphoinositide 3-kinase beta (PI3Kβ) and delta (PI3Kδ), blocking downstream AKT phosphorylation and phosphoinositide 3-kinase signal transduction. By halting these critical signaling cascades, the compound suppresses tumor cell proliferation, providing therapeutic relevance for treating PTEN- or PIK3CB-mutated solid tumors including prostate, breast, and gastric cancers evaluated in 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>).