RAF265 (CHIR-265) Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 557

Clinical Trials

Multiple clinical trials have evaluated RAF265 (CHIR-265) in Phase 1 and Phase 1/2 settings for patients with metastatic melanoma or advanced solid tumors harboring RAS or BRAFV600E mutations. Sponsored by Novartis Pharmaceuticals and Array BioPharma (now a subsidiary of Pfizer), these completed studies evaluated safety, pharmacokinetics, and combination regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00304525	COMPLETED	Metastatic Melanoma	Novartis Pharmaceuticals	2006-04	PHASE1; PHASE2
NCT01352273	COMPLETED	Advanced Solid Tumors	Array Biopharma, now a wholly owned subsidiary of Pfizer	2011-06	PHASE1
NCT01352273	Completed	Advanced Solid Tumors	Array Biopharma now a wholly owned subsidiary of Pfizer\|Array BioPharma	2011-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-12-19)

Check the RAF265 (CHIR-265) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RAF265 selectively binds to C-Raf, B-Raf (including B-Raf V600E), and VEGFR2, thereby blocking downstream signaling through the RAS/RAF/MEK/ERK pathway and inhibiting VEGFR2 autophosphorylation. This inhibition triggers cell cycle arrest, induces apoptosis, and impairs vascular endothelial function to suppress growth in advanced solid tumors and metastatic melanoma.

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>).