XL413 Hydrochloride (BMS-863233) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 470

Clinical Trials

Several Phase 1/2 clinical trials, sponsored by Bristol-Myers Squibb in collaboration with Exelixis, have evaluated the safety, pharmacokinetics, and pharmacodynamics of XL413 (BMS-863233) in human subjects. These multiple ascending dose protocols targeted patient populations suffering from advanced solid cancers, metastatic cancer, and refractory hematologic malignancies. According to current records, all of these clinical trials have been officially terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00886782	Terminated	Advanced Solid Cancers\|Metastatic Cancer	Bristol-Myers Squibb\|Exelixis	2009-05-31	Phase 1\|Phase 2
NCT00838890	Terminated	Refractory Hematologic Cancer	Bristol-Myers Squibb\|Exelixis	2009-03	Phase 1\|Phase 2

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

Check the XL413 Hydrochloride (BMS-863233) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

XL413 Hydrochloride acts as a potent and selective inhibitor of cell division cycle 7 homolog (CDC7) kinase with an IC50 of 3.4 nM, effectively preventing downstream phosphorylation of MCM2 to disrupt the initiation of genomic DNA replication. By halting S-phase cell cycle progression and suppressing aberrant cell proliferation, this targeted mechanism seeks to inhibit tumor growth in patients with advanced solid cancers, metastatic tumors, and refractory hematologic 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>).