CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
MLN8237drug
Likely dose
MLN8237 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01799278
NCT01799278Phase 2Completed
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A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

Weill Medical College of Cornell University·interventional·Posted Feb 26, 2013·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating MLN8237 for Small Cell Prostate Cancer and 2 related conditions. Completed, enrolled 60 participants across 8 sites.

Detailed Summary

This study will evaluate the response rate of MLN8237 in patients with histologically confirmed or clinically suspected metastatic neuroendocrine prostate cancer (NEPC). MLN8237 is an orally administered Aurora kinase A inhibitor that has demonstrated broad antitumor activity in vitro and in vivo. In preclinical models, aurora kinase inhibition resulted in dramatic and preferential anti-tumor activity in NEPC with suppression of neuroendocrine marker expression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Prostate Cancer, Neuroendocrine Prostate Cancer, Prostate Adenocarcinoma Plus > 50% Immunohistochemical Staining for Neuroendocrine Markers
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJul 1, 2016
Study CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.3 years ago

Interventions

MLN8237drug

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.