Docetaxel Trihydrate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 247

Clinical Trials

Multiple clinical trials are evaluating Docetaxel for advanced malignancies, including squamous cell non-small cell lung cancer, primary prostate cancer, and metastatic castrate-resistant prostate adenocarcinoma. These studies—encompassing Phase 2, Phase 3, and unclassified phase protocols—are sponsored by entities such as Shanghai JMT-Bio Inc., the Hospital of Macerata, and The University of Texas Health Science Center at San Antonio. Current recruitment statuses across these studies range from not yet recruiting to withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06319313	Not yet recruiting	Squamous Cell Non-small Cell Lung Cancer	Shanghai JMT-Bio Inc.	2024-05-01	Phase 2\|Phase 3
NCT06200558	Not yet recruiting	Prostate Cancer	Hospital of Macerata	2024-01-31	--
NCT05156372	Withdrawn	Prostate Cancer Metastatic\|Castrate Resistant Prostate Cancer\|Metastatic Prostate Cancer\|Metastatic Prostate Adenocarcinoma	The University of Texas Health Science Center at San Antonio	2023-12	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Docetaxel Trihydrate binds directly to tubulin within stabilized microtubules, inhibiting microtubule depolymerization and disrupting normal mitotic spindle assembly. This disruption induces cell cycle arrest at the G2/M transition and triggers apoptotic cell death, thereby halting tumor growth in malignancies such as prostate cancer and squamous cell 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>).