Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer

Summary

This phase I/II trial studies the side effects and best dose of alisertib when given together with abiraterone acetate and prednisone and to see how well it works in treating patients with hormone-resistant prostate cancer. Alisertib and abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate, may also lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alisertib, abiraterone acetate, and prednisone together may be an effective treatment for prostate cancer.

Timeline

Start

2013-08-14

Primary completion

2015-03-03

Completion

2016-06-23

Publications

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• Background Dees EC, Infante JR, Cohen RB, O'Neil BH, Jones S, von Mehren M, Danaee H, Lee Y, Ecsedy J, Manfredi M, Galvin K, Stringer B, Liu H, Eton O, Fingert H, Burris H. Phase 1 study of MLN8054, a selective inhibitor of Aurora A kinase in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Apr;67(4):945-54. doi: 10.1007/s00280-010-1377-y. Epub 2010 Jul 7.
• Lin J, Patel SA, Sama AR, Hoffman-Censits JH, Kennedy B, Kilpatrick D, Ye Z, Yang H, Mu Z, Leiby B, Lewis N, Cristofanilli M, Kelly WK. A Phase I/II Study of the Investigational Drug Alisertib in Combination With Abiraterone and Prednisone for Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Abiraterone. Oncologist. 2016 Nov;21(11):1296-1297e. doi: 10.1634/theoncologist.2016-0297. Epub 2016 Oct 24.

Drugs

Indications