R547 Clinical Trials

Size	Price	Qty
2mg	USD 470
5mg	USD 670

Clinical Trials

Multiple clinical trials sponsored by Hoffmann-La Roche have evaluated R547 in patients diagnosed with neoplasms and advanced solid tumors. These completed Phase 1 studies assessed multiple ascending intravenous doses on a weekly schedule. Collectively, these trials establish the primary clinical research scope of R547 in solid tumor oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00400296	COMPLETED	Neoplasms	Hoffmann-La Roche	2005-05	PHASE1
NCT00400296	Completed	Neoplasms	Hoffmann-La Roche	2005-05	Phase 1

(data from https://clinicaltrials.gov, updated on 2016-11-02)

Check the R547 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

R547 functions as an ATP-competitive inhibitor of cyclin-dependent kinases CDK1, CDK2, and CDK4, effectively suppressing CDK-mediated downstream signaling and arresting cell cycle progression. By blocking dysregulated cellular proliferation and inducing apoptosis in malignant cells, this target inhibition provides the biological rationale for its clinical investigation in neoplasms and 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>).