A Phase II Trial of MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

August 31, 2017

Conditions
Small Cell Prostate CancerNeuroendocrine Prostate CancerProstate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers
Interventions
DRUG

MLN8237

MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.

Trial Locations (8)

10021

Memorial Sloan-Kettering Cancer Center, New York

10065

Weill Cornell Medical College, New York

27710

Duke University Health System, Durham

44106

University Hospitals Cleveland Medical Center, Cleveland

48201

Karmanos Cancer Institute, Detroit

60637

University of Chicago, Chicago

98195

University of Washington Medical Center, Seattle

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER