SAR125844 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Several completed clinical trials sponsored by Sanofi have evaluated intravenous SAR125844 for the treatment of malignant solid tumors and neoplasms across Phase 1 and Phase 2 studies. Initial investigations established the safety, pharmacokinetics, and pharmacodynamics of the compound across diverse patient cohorts. Subsequently, a clinical trial assessed the therapeutic benefit of weekly single-agent intravenous infusions in patients with malignant neoplasms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02435121	Completed	Neoplasm Malignant	Sanofi	2015-11	Phase 2
NCT01657214	Completed	Neoplasm Malignant	Sanofi	2012-09	Phase 1
NCT01391533	Completed	Malignant Solid Tumors	Sanofi	2011-07	Phase 1

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

Check the SAR125844 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SAR125844 selectively binds to and inhibits the catalytic activity of both wild-type Met (c-Met) kinase and its domain mutants, blocking downstream oncogenic signal transduction cascades. By suppressing c-Met-driven intracellular signaling, the compound impairs tumor cell proliferation and survival, providing a rational biochemical mechanism for inhibiting malignant solid tumor growth in clinical settings.

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>).