OSI-930 Clinical Trials

Size	Price	Qty
5mg	USD 150

Clinical Trials

The clinical trial landscape for OSI-930 includes a completed Phase I clinical trial investigating daily oral administration of the compound via a dose-escalation design in patients with advanced solid tumors. Jointly sponsored by pharmaceutical industry entities Astellas Pharma Inc and OSI Pharmaceuticals, the study evaluated safety, tolerability, and initial therapeutic parameters. Consequently, clinical evaluation of this agent remains focused on early-stage safety profiles and preliminary activity within advanced solid malignancy populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00513851	Completed	Advanced Solid Tumors	Astellas Pharma Inc\|OSI Pharmaceuticals	2006-04	Phase 1

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

Check the OSI-930 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OSI-930 acts as a potent multi-targeted receptor tyrosine kinase inhibitor that selectively binds to c-Kit, VEGFR-2, and CSF-1R, thereby blocking downstream pro-survival and angiogenic signaling pathways. By simultaneously suppressing tumor cell proliferation and vascular endothelial growth, this dual inhibition disrupts tumor microenvironment maintenance, demonstrating therapeutic relevance in targeting advanced 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>).