Amuvatinib (MP-470) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Multiple clinical trials sponsored primarily by Astex Pharmaceuticals, Inc. have evaluated amuvatinib (MP-470) across Phase I and Phase II studies for malignant diseases, including small cell lung carcinoma, lymphoma, and advanced solid tumors. Early-phase safety and dose-finding studies examined oral amuvatinib monotherapy and combinations with standard chemotherapy regimens, including platinum-etoposide for small cell lung cancer. Although several trials achieved completed status, certain early-stage investigations were terminated prior to full completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01357395	COMPLETED	Small Cell Lung Carcinoma	Astex Pharmaceuticals, Inc.	2011-05	PHASE2
NCT01357395	Completed	Small Cell Lung Carcinoma	Astex Pharmaceuticals Inc.	2011-05	Phase 2
NCT00881166	COMPLETED	Malignant Disease	Astex Pharmaceuticals, Inc.	2007-11	PHASE1
NCT00894894	COMPLETED	Solid Tumors	Astex Pharmaceuticals, Inc.	2007-05	PHASE1
NCT00504205	TERMINATED	Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific	Astex Pharmaceuticals, Inc.	2007-05

(data from https://clinicaltrials.gov, updated on 2024-08-02)

Check the Amuvatinib (MP-470) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amuvatinib functions as a multi-targeted receptor tyrosine kinase inhibitor that potently binds to c-Kit, PDGFRalpha, FLT3, c-Met, and RET while additionally suppressing Rad51-mediated homologous recombination DNA repair, thereby disrupting oncogenic kinase signaling cascades and impairing double-strand DNA break repair. This dual action downregulates anti-apoptotic signaling and sensitizes malignant cells to radiation and cytotoxic agents, providing the therapeutic rationale for its evaluation in clinical trials targeting small cell lung carcinoma, advanced solid tumors, and lymphoma.

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>).