A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer.

International Journal of Clinical Oncology
Hideyuki AkazaSeiji Naito

Abstract

The safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of enzalutamide were investigated in patients with castration-resistant prostate cancer (CRPC) in Japan through a multicenter phase I/II study. In phase I, patients with progressive metastatic CRPC received single, then multiple, ascending doses of enzalutamide 80, 160 or 240 mg/day. After assessment of tolerability at multiple doses of 160 mg/day for 4 weeks, post-docetaxel patients with CRPC and measurable disease were enrolled into phase II; receiving long-term administration of enzalutamide 160 mg/day. Nine and 38 patients were enrolled in phase I and II, respectively. During phase I, enzalutamide was well tolerated in each cohort; PK parameters were similar to those of non-Japanese populations in other studies. By week 12, overall response rate was 5.3 % and clinical benefit rate was 47.4 %. Prostate-specific antigen response rate (≥50 % reduction from baseline) was 28.9 %. Treatment-emergent adverse events reported in >20 % of patients in phase II were decreased weight, decreased appetite and constipation. No seizures were observed. Enzalutamide at 160 mg/day was well tolerated, with PK and safety profiles similar to the non-Japanese population. Anti-...Continue Reading

References

Mar 1, 1992·Human Pathology·D F Gleason
Oct 8, 2004·The New England Journal of Medicine·Ian F TannockUNKNOWN TAX 327 Investigators
Oct 30, 2007·Japanese Journal of Clinical Oncology·Shiro HinotsuUNKNOWN Japan Study Group of Prostate Cancer (J-CaP)
Mar 4, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Howard I ScherUNKNOWN Prostate Cancer Clinical Trials Working Group
Jun 19, 2009·Cancer·Hideyuki AkazaUNKNOWN Study Group for the Combined Androgen Blockade Therapy of Prostate Cancer
Feb 18, 2010·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Charles J RyanEric J Small
Apr 20, 2010·Lancet·Howard I ScherUNKNOWN Prostate Cancer Foundation/Department of Defense Prostate Cancer Clinical Trials Consortium
Sep 8, 2010·The New England Journal of Medicine·Philip W KantoffUNKNOWN IMPACT Study Investigators
May 27, 2011·The New England Journal of Medicine·Johann S de BonoUNKNOWN COU-AA-301 Investigators
Aug 17, 2012·The New England Journal of Medicine·Howard I ScherUNKNOWN AFFIRM Investigators
Dec 12, 2012·The New England Journal of Medicine·Charles J RyanUNKNOWN COU-AA-302 Investigators
Apr 12, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·Y LoriotC Massard
Jul 19, 2013·The New England Journal of Medicine·C ParkerUNKNOWN ALSYMPCA Investigators
Feb 12, 2014·Japanese Journal of Clinical Oncology·Naoto KamiyaTsuneharu Miki
Jun 3, 2014·The New England Journal of Medicine·Tomasz M BeerUNKNOWN PREVAIL Investigators
Aug 8, 2014·Japanese Journal of Clinical Oncology·Mizuki OnozawaHideyuki Akaza
Sep 4, 2014·The New England Journal of Medicine·Emmanuel S AntonarakisJun Luo
Jul 1, 2013·Annals of Oncology : Official Journal of the European Society for Medical Oncology·Y LoriotC Massard

❮ Previous
Next ❯

Citations

Nov 16, 2021·International Journal of Clinical Oncology·Akira YokomizoNorio Nonomura

❮ Previous
Next ❯

Methods Mentioned

BETA
nuclear translocation

Clinical Trials Mentioned

NCT01284920
NCT00510718

Software Mentioned

MedDRA
SAS Drug Development
SAS
PC
PREVAIL
Cap
WinNonlin
AFFIRM

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Therapeutic Advances in Urology
Axel S MerseburgerChristoph-A von Klot
Annals of Oncology : Official Journal of the European Society for Medical Oncology
M D MichaelsonMatthew R Smith
Clinical Medicine Insights. Oncology
Joelle El-AmmJeanny B Aragon-Ching
© 2022 Meta ULC. All rights reserved