@article{04d1ad1e39c146ad93f2cc5ec6dccea1,
title = "Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment",
abstract = "We conducted an open-label phase 2 clinical study to evaluate the safety and efficacy of seviteronel (provided once or twice daily without oral steroids) in patients with metastatic castration-resistant prostate cancer previously treated with enzalutamide. The study was terminated early as a result of suboptimal dosing strategies and significant central nervous system toxicity. Further evaluation of seviteronel is not warranted in this patient population as a result of limited tolerability and insufficient clinical activity.",
keywords = "Acquired resistance, Androgen receptor, CYP17 inhibitor, Pharmacokinetics, mCRPC",
author = "Madan, {Ravi A.} and Schmidt, {Keith T.} and Fatima Karzai and Peer, {Cody J.} and Cordes, {Lisa M.} and Chau, {Cindy H.} and Steinberg, {Seth M.} and Helen Owens and Joel Eisner and Moore, {William R.} and Dahut, {William L.} and Gulley, {James L.} and Figg, {William D.}",
note = "Funding Information: We thank the nursing staff of National Cancer Institute and the fellows of the Genitourinary Malignancies Branch at National Cancer Institute for their care of our patients, and Peraton for data management assistance. Most importantly, we appreciate the patients with cancer who enroll onto investigational trials to advance the knowledge of this disease. This work was supported by the Intramural Research Program of the Center for Cancer Research, National Cancer Institute, National Institutes of Health. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. Funding Information: We thank the nursing staff of National Cancer Institute and the fellows of the Genitourinary Malignancies Branch at National Cancer Institute for their care of our patients, and Peraton for data management assistance. Most importantly, we appreciate the patients with cancer who enroll onto investigational trials to advance the knowledge of this disease. This work was supported by the Intramural Research Program of the Center for Cancer Research , National Cancer Institute , National Institutes of Health . The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. Publisher Copyright: {\textcopyright} 2019",
year = "2020",
month = aug,
doi = "10.1016/j.clgc.2019.11.002",
language = "English",
volume = "18",
pages = "258--267.e1",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
number = "4",
}