XL228 Clinical Trials

Size	Price	Qty
5mg	USD 167
25mg	USD 509

Clinical Trials

Multiple clinical trials sponsored by the industry sponsor Exelixis have evaluated intravenously administered XL228. These early-stage Phase 1 dose-escalation studies investigated the safety, pharmacokinetics, and pharmacodynamics of the drug in patients with advanced solid cancers, lymphoma, chronic myeloid leukemia, or Philadelphia chromosome-positive acute lymphoblastic leukemia. Recruitment for these oncological and hematological trials has reached a terminated status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00526838	Terminated	Cancer\|Lymphoma	Exelixis	2007-09	Phase 1
NCT00464113	Terminated	Chronic Myeloid Leukemia\|Leukemia Lymphoblastic Acute Philadelphia-Positive	Exelixis	2007-05	Phase 1

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

Check the XL228 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

XL228 acts as a potent multi-kinase inhibitor that binds to and inhibits wild-type ABL, ABL T315I mutant, Aurora A, IGF-1R, SRC, and LYN kinases, thereby blocking downstream oncogenic tyrosine kinase signaling cascades essential for cellular survival. By arresting cell cycle progression and promoting targeted cell death, XL228 exhibits anti-tumor activity relevant to the treatment of advanced solid tumors, lymphoma, chronic myeloid leukemia, and Philadelphia chromosome-positive acute lymphoblastic leukemia.

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>).