AZD8835 Clinical Trials

Size	Price	Qty
5mg	USD 137
25mg	USD 447

Clinical Trials

A completed Phase 1 clinical trial sponsored by AstraZeneca evaluated the safety, tolerability, and pharmacokinetics of AZD8835 in patients with advanced solid malignancies. This open-label, multicenter, dose-escalation study focused on estrogen receptor-positive, HER2-negative breast cancer, including tumors bearing PIK3CA gene mutations. The trial provided the primary assessment of the compound's baseline clinical feasibility and pharmacological characteristics in oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02260661	Completed	Advanced Solid Malignancies\|Breast Cancer - ER+ HER2 -\|Breast Cancer - ER+ HER2- PIK3CA Gene Mutation	AstraZeneca	2014-11	Phase 1

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

Check the AZD8835 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD8835 selectively binds to phosphoinositide 3-kinase alpha (PI3Kα) and delta (PI3Kδ) isoforms to block downstream intracellular AKT phosphorylation and disrupt essential oncogenic survival cascades within target cells. This pathway suppression reduces lipid kinase activity and impairs tumor cell proliferation, providing a mechanistically targeted approach for treating advanced solid malignancies and ER-positive, HER2-negative breast cancers harboring PIK3CA gene mutations.

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>).