Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies

Summary

This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity. In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.

Timeline

Start

2010-04-27

Primary completion

2015-10-22

Completion

2015-10-27

Outcome

Outcome not reported

Stopped: “Toxicity was not felt to be acceptable for further development.”

Publications

• Results Phatak P, Dai F, Butler M, Nandakumar MP, Gutierrez PL, Edelman MJ, Hendriks H, Burger AM. KML001 cytotoxic activity is associated with its binding to telomeric sequences and telomere erosion in prostate cancer cells. Clin Cancer Res. 2008 Jul 15;14(14):4593-602. doi: 10.1158/1078-0432.CCR-07-4572.

Drugs

Indications