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

Research output: Contribution to journal › Article › peer-review

16 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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10.1016/j.clgc.2019.11.002

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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 - https://www.scopus.com/pages/publications/85083367013

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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