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TPS5085 : Randomized, open-label, multicenter, controlled study of galeterone vs enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC) expressing AR-V7 splice variant (ARMOR3-SV).

Researchers

Presenter

  • Emmanuel S. Antonarakis

Principal Investigators

  • Johann S. De Bono

  • Karen J. Ferrante

  • Kerry Horgan

  • Jun Luo

  • Fred Saad

  • Mary-Ellen Taplin

Medical Centers

  • The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, MD

  • Royal Marsden NHS Foundation Trust, The Institute of Cancer Research, London, United Kingdom

  • Tokai Pharmaceuticals, Boston, MA

  • Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD

  • University of Montreal, Montreal, QC, Canada

  • Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA

Locations

  • United States

  • Canada

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

  • Urology

Disease

  • Metastatic castration-resistant prostate cancer

Biomarkers

  • Androgen receptor variant 7

  • Circulating tumor cells

  • Prostate specific antigen

Drug/Treatment

  • Enzalutamide

  • CB-7598

  • Galeterone

  • Methadone hydrochloride

Outcome

  • N/A


Study Design

  • Randomized

  • Pharmacokinetics

  • Double Blind/Blinded

  • Open Label

  • Multicenteric

  • Controlled

Phase

  • III

Study Id's

  • NCT02438007

Sponsors

  • N/A

Result

  • N/A