AZD2461 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 377

Clinical Trials

Sponsored by AstraZeneca, multiple clinical trials evaluated the safety, pharmacokinetics, and pharmacodynamics of AZD2461 in patients with advanced cancer and refractory solid tumors. These early-stage, Phase 1 open-label evaluations incorporated dose-escalation protocols to establish the compound's biological activity profile. Having reached completed status, these clinical trials provide foundational safety and pharmacokinetic parameters for AZD2461 in oncology indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01247168	COMPLETED	Refractory Solid Tumors; Cancer Tumor	AstraZeneca	2010-11	PHASE1
NCT01247168	Completed	Refractory Solid Tumors\|Cancer Tumor	AstraZeneca	2010-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2012-06-06)

Check the AZD2461 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD2461 selectively binds to poly(ADP-ribose) polymerase (PARP) and inhibits single-strand DNA repair, leading to replication fork collapse, double-strand DNA accumulation, and synthetic lethality in targeted cells. By disrupting essential DNA repair pathways to induce tumor cell apoptosis, this targeted activity underlines its therapeutic rationale in treating refractory solid tumors.

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>).