SNS-032 (BMS-387032) Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 570

Clinical Trials

Sponsored by Sunesis Pharmaceuticals, several completed Phase I clinical trials evaluated the safety, tolerability, and pharmacokinetics of intravenous SNS-032 (BMS-387032) during dose escalation. These studies involved patients with advanced solid tumors and relapsed or refractory B-lymphoid malignancies, including chronic lymphocytic leukemia, mantle cell lymphoma, and multiple myeloma. Ultimately, these trials confirmed the clinical feasibility and tolerability profile of CDK inhibition using SNS-032 across both solid and hematologic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00446342	COMPLETED	B-lymphoid Malignancies; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Multiple Myeloma	Sunesis Pharmaceuticals	2007-02	PHASE1
NCT00446342	Completed	B-lymphoid Malignancies\|Chronic Lymphocytic Leukemia\|Mantle Cell Lymphoma\|Multiple Myeloma	Sunesis Pharmaceuticals	2007-02	Phase 1
NCT00292864	COMPLETED	Tumors	Sunesis Pharmaceuticals	2006-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2017-04-11)

Check the SNS-032 (BMS-387032) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SNS-032 selectively binds to and inhibits cyclin-dependent kinases CDK2, CDK7, and CDK9, thereby suppressing downstream transcription factor phosphorylation and blocking signal pathways essential for angiogenesis. This multi-kinase inhibition triggers robust cell cycle arrest and apoptosis, mediating antitumor activity relevant to its clinical evaluation in advanced solid tumors and B-lymphoid malignancies.

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>).