Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment

Ravi A. Madan; Keith T. Schmidt; Fatima Karzai; Cody J. Peer; Lisa M. Cordes; Cindy H. Chau; Seth M. Steinberg; Helen Owens; Joel Eisner; William R. Moore; William L. Dahut; James L. Gulley; William D. Figg

doi:10.1016/j.clgc.2019.11.002

Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment

Ravi A. Madan, Keith T. Schmidt, Fatima Karzai, Cody J. Peer, Lisa M. Cordes, Cindy H. Chau, Seth M. Steinberg, Helen Owens, Joel Eisner, William R. Moore, William L. Dahut, James L. Gulley, William D. Figg^*

^*Corresponding author for this work

Surgery

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15 Scopus citations

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.

Original language	English
Pages (from-to)	258-267.e1
Journal	Clinical Genitourinary Cancer
Volume	18
Issue number	4
DOIs	https://doi.org/10.1016/j.clgc.2019.11.002
State	Published - Aug 2020

Keywords

Acquired resistance
Androgen receptor
CYP17 inhibitor
Pharmacokinetics
mCRPC

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Madan, R. A., Schmidt, K. T., Karzai, F., Peer, C. J., Cordes, L. M., Chau, C. H., Steinberg, S. M., Owens, H., Eisner, J., Moore, W. R., Dahut, W. L., Gulley, J. L., & Figg, W. D. (2020). Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment. Clinical Genitourinary Cancer, 18(4), 258-267.e1. https://doi.org/10.1016/j.clgc.2019.11.002

@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 = "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",

publisher = "Elsevier Inc.",

number = "4",

}

Madan, RA, Schmidt, KT, Karzai, F, Peer, CJ, Cordes, LM, Chau, CH, Steinberg, SM, Owens, H, Eisner, J, Moore, WR, Dahut, WL, Gulley, JL & Figg, WD 2020, 'Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment', Clinical Genitourinary Cancer, vol. 18, no. 4, pp. 258-267.e1. https://doi.org/10.1016/j.clgc.2019.11.002

TY - JOUR

T1 - Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment

AU - Madan, Ravi A.

AU - Schmidt, Keith T.

AU - Karzai, Fatima

AU - Peer, Cody J.

AU - Cordes, Lisa M.

AU - Chau, Cindy H.

AU - Steinberg, Seth M.

AU - Owens, Helen

AU - Eisner, Joel

AU - Moore, William R.

AU - Dahut, William L.

AU - Gulley, James L.

AU - Figg, William D.

PY - 2020/8

Y1 - 2020/8

N2 - 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.

AB - 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.

KW - Acquired resistance

KW - Androgen receptor

KW - CYP17 inhibitor

KW - Pharmacokinetics

KW - mCRPC

UR - http://www.scopus.com/inward/record.url?scp=85083367013&partnerID=8YFLogxK

U2 - 10.1016/j.clgc.2019.11.002

DO - 10.1016/j.clgc.2019.11.002

M3 - Article

C2 - 32327394

AN - SCOPUS:85083367013

SN - 1558-7673

VL - 18

SP - 258-267.e1

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

IS - 4

ER -

Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment

Abstract

Keywords

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