Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

Summary

This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.

Timeline

Start

2023-10-24

Primary completion

2028-11

Completion

2028-11

Publications

• Background Foss FM, Parker T. A Phase I Dose-Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low-Grade or Intermediate-Grade B-Cell or T-Cell Lymphoma. Oncologist. 2018 Apr;23(4):397-e30. doi: 10.1634/theoncologist.2017-0658. Epub 2018 Feb 7.
• Background Kantarjian HM, Erba HP, Claxton D, Arellano M, Lyons RM, Kovascovics T, Gabrilove J, Craig M, Douer D, Maris M, Petersdorf S, Shami PJ, Yeager AM, Eckert S, Abichandani R, Faderl S. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010 Feb 1;28(4):549-55. doi: 10.1200/JCO.2009.23.3130. Epub 2009 Dec 21.
• Background Kantarjian HM, Gandhi V, Kozuch P, Faderl S, Giles F, Cortes J, O'Brien S, Ibrahim N, Khuri F, Du M, Rios MB, Jeha S, McLaughlin P, Plunkett W, Keating M. Phase I clinical and pharmacology study of clofarabine in patients with solid and hematologic cancers. J Clin Oncol. 2003 Mar 15;21(6):1167-73. doi: 10.1200/JCO.2003.04.031.
• Background Zhenchuk A, Lotfi K, Juliusson G, Albertioni F. Mechanisms of anti-cancer action and pharmacology of clofarabine. Biochem Pharmacol. 2009 Dec 1;78(11):1351-9. doi: 10.1016/j.bcp.2009.06.094. Epub 2009 Jul 1.
• Background Gutmann M, Ertl IE, Herek P, Vician P, Pirker C, Nossing C, Brettner R, Lemberger U, Grausenburger R, Batlogg K, Baumfried O, Prantl I, Singh N, Laukhtina E, Oszwald A, Wasinger G, Comperat E, Berger W, Shariat SF, Englinger B. Clofarabine Has a Superior Therapeutic Window as compared to Gemcitabine in Preclinical Bladder Cancer Models. Eur Urol Oncol. 2024 Dec;7(6):1166-1170. doi: 10.1016/j.euo.2024.05.001. Epub 2024 May 16.
• Background Ertl IE, Lemberger U, Ilijazi D, Hassler MR, Bruchbacher A, Brettner R, Kronabitter H, Gutmann M, Vician P, Zeitler G, Koren A, Lardeau CH, Mohr T, Haitel A, Comperat E, Oszwald A, Wasinger G, Clozel T, Elemento O, Kubicek S, Berger W, Shariat SF. Molecular and Pharmacological Bladder Cancer Therapy Screening: Discovery of Clofarabine as a Highly Active Compound. Eur Urol. 2022 Sep;82(3):261-270. doi: 10.1016/j.eururo.2022.03.009. Epub 2022 Apr 4.

Drugs

Indications