MGCD-265 analog Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by Mirati Therapeutics Inc. have investigated MGCD-265 across advanced malignancies, non-small cell lung cancer (NSCLC), and healthy subjects. These Phase 1, Phase 2, and Phase 1/2 studies evaluated the drug's bioavailability, dosage, and therapeutic efficacy as monotherapy or in combination with other anti-cancer agents. While completed Phase 1 studies assessed oral formulations and a Phase 2 trial focused on NSCLC harboring activating genetic alterations, another evaluation was terminated early during combination therapy testing.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02544633	Completed	Non-Small Cell Lung Cancer	Mirati Therapeutics Inc.	2015-10	Phase 2
NCT01930006	Completed	Advanced Malignancies	Mirati Therapeutics Inc.	2013-08	Phase 1
NCT02117245	Completed	Healthy	Mirati Therapeutics Inc.	2011-12	--
NCT00975767	Terminated	Advanced Malignancies Non-small Cell Lung Cancer	Mirati Therapeutics Inc.	2009-08	Phase 1

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

Check the MGCD-265 analog product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MGCD-265 functions as an ATP-competitive multi-kinase inhibitor that selectively targets c-Met, VEGFR1/2/3, Ron, and Tie2 receptor tyrosine kinases, thereby blocking receptor auto-phosphorylation and downstream intracellular signaling cascades essential for angiogenesis and cellular survival. This targeted inhibition suppresses vascular endothelial cell proliferation and tumor cell growth, providing a strong pharmacological rationale for its clinical evaluation in advanced malignancies and non-small cell lung 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>).