LY3009120 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

Multiple clinical trials sponsored by the pharmaceutical company Eli Lilly and Company have investigated the therapeutic profile of LY3009120 in human subjects. These Phase I evaluations aimed to assess safety, dosage, and preliminary efficacy across advanced solid malignancies, specifically encompassing neoplasms, neoplasm metastasis, melanoma, non-small-cell lung carcinoma, and colorectal neoplasms. Across the clinical record, the recruitment status for these trials is listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02014116	TERMINATED	Neoplasms; Neoplasm Metastasis; Melanoma; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms	Eli Lilly and Company	2013-11-26	PHASE1
NCT02014116	Terminated	Neoplasms\|Neoplasm Metastasis\|Melanoma\|Carcinoma Non-Small-Cell Lung\|Colorectal Neoplasms	Eli Lilly and Company	2013-11-26	Phase 1

(data from https://clinicaltrials.gov, updated on 2019-12-27)

Check the LY3009120 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3009120 functions as a potent pan-Raf inhibitor that directly binds to A-Raf, B-Raf, and C-Raf, thereby suppressing downstream kinase signaling and inducing cellular autophagy. By interrupting Raf-mediated signal transduction and halting tumor cell proliferation, this target pathway inhibition is clinically relevant for controlling neoplastic growth in conditions such as melanoma, non-small-cell lung carcinoma, and metastatic colorectal cancer.

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>).