Clinical Trials

According to clinical registry records, TAS-119 has been evaluated in a clinical trial sponsored by Taiho Oncology Inc. This Phase 1 study investigated the safety, tolerability, and pharmacokinetic profile of TAS-119 in combination with paclitaxel in patients diagnosed with advanced solid tumors. However, recruitment for the study was ultimately terminated, representing the extent of recorded clinical evaluation for this investigational agent.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02134067 Terminated
Advanced Solid Tumors
Taiho Oncology Inc.
 2014-08 Phase 1

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

Check the TAS-119 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAS-119 functions as a potent inhibitor of Aurora A kinase (IC50 = 1.0 nM) and Aurora B kinase (IC50 = 95 nM), binding to the catalytic domain to disrupt target kinase phosphorylation and impair mitotic spindle formation. This biochemical blockade induces aberrant chromosome segregation, mitotic cell cycle arrest, and apoptosis, providing a mechanistic basis for suppressing tumor growth in advanced solid tumors.

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>).

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Note: Technical data last updated: Sep 1, 2026.