Clinical Trials

A clinical trial sponsored by Amsterdam UMC, location VUmc, evaluated patients with solid tumors in a phase 1 setting. This completed study assessed the biodistribution and tumor accumulation of a novel docetaxel formulation via molecular imaging, offering early-phase clinical insights into drug delivery for solid tumor malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03712423 COMPLETED
Solid Tumor
Amsterdam UMC, location VUmc
 2018-04-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-10-08)

Check the H-89 Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

H-89 Dihydrochloride selectively binds to and inhibits protein kinase A, which blocks downstream substrate phosphorylation and interrupts intracellular signaling cascades necessary for cellular proliferation. By suppressing these kinase-driven pathways and inducing autophagy, the compound reduces tumor cell survival, which is directly relevant to the treatment of 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.