Clinical Trials

Voreloxin (SNS-595) has been evaluated across multiple clinical trials—spanning Phase I, Phase II, and Phase I/II—targeting acute myeloid leukemia, myelodysplastic syndromes, epithelial ovarian cancer, and small cell lung cancer. Sponsored by Sunesis Pharmaceuticals alongside academic medical centers including M.D. Anderson, Washington University, and Vanderbilt-Ingram, these studies assessed Voreloxin as monotherapy and combined with cytarabine, azacitidine, or decitabine. The majority of these registered trials are currently completed or active, not recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02658487 Active not recruiting
Acute Myeloid Leukemia|Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome|Acute Myeloid Leukemia With Multilineage Dysplasia|Myeloid Sarcoma|Secondary Acute Myeloid Leukemia|Therapy-Related Acute Myeloid Leukemia|Therapy-Related Myelodysplastic Syndrome
Vanderbilt-Ingram Cancer Center|National Cancer Institute (NCI)
 2016-03 Phase 2
NCT01913951 Completed
Myelodysplastic Syndromes
Washington University School of Medicine|Sunesis Pharmaceuticals
 2013-11-22 Phase 1
NCT01980056 Completed
Myelodysplastic Syndrome
Weill Medical College of Cornell University|Sunesis Pharmaceuticals
 2013-10-25 Phase 1|Phase 2
NCT01893320 Completed
Leukemia
M.D. Anderson Cancer Center|Sunesis Pharmaceuticals
 2013-07-18 Phase 1|Phase 2
NCT00541866 COMPLETED
Acute Myeloid Leukemia
Sunesis Pharmaceuticals
 2007-10-06 PHASE1; PHASE2
NCT00408603 COMPLETED
Epithelial Ovarian Cancer
Sunesis Pharmaceuticals
 2006-12-20 PHASE2
NCT00607997 COMPLETED
Leukemia; Acute Disease; Acute Myeloid Leukemia; Nonlymphocytic Leukemia; Myelodysplastic Syndromes
Sunesis Pharmaceuticals
 2008-05-15 PHASE2
NCT00246662 COMPLETED
Leukemia, Lymphocytic, Acute; Leukemia, Nonlymphocytic, Acute; Leukemia, Myeloid, Chronic; Myelodysplastic Syndromes
Sunesis Pharmaceuticals
 2005-11-14 PHASE1
NCT00298896 COMPLETED
Carcinoma, Small Cell; Small Cell Lung Cancer
Sunesis Pharmaceuticals
 2006-02 PHASE2
NCT00252382 COMPLETED
Carcinoma, Non-Small-Cell Lung
Sunesis Pharmaceuticals
 2005-12-27 PHASE2
NCT00094159 COMPLETED
Neoplasms
Sunesis Pharmaceuticals
 2004-10 PHASE1
NCT00091585 COMPLETED
Neoplasms
Sunesis Pharmaceuticals
 2004-06 PHASE1

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

Check the Voreloxin (SNS-595) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voreloxin hydrochloride intercalates into DNA and inhibits topoisomerase II, inducing site-specific double-strand DNA breaks and arresting cell cycle progression in the G2 phase. This pronounced DNA damage triggers apoptotic cell death pathways, providing targeted cytotoxicity against rapidly proliferating neoplastic cells in acute myeloid leukemia and myelodysplastic syndromes.

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.