A Phase II Study of MLN8237 in Patients with Advanced Prostate Cancer

Protocol
13-042
Full Title
A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
Phase
II
Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). Over time, however, many prostate cancers continue to grow despite hormonal therapies (“castration-resistant” prostate cancer). Some prostate cancers have features called “neuroendocrine markers” which do not respond well to hormonal therapies or other therapies that are used to treat typical advanced prostate cancer.

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called MLN8237 in men with metastatic castration-resistant prostate cancer with neuroendocrine features. MLN8237 works by blocking aurora kinase, an enzyme that helps cancer cells divide and reproduce. MLN8237 is a pill that is taken by mouth.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic prostate cancer with neuroendocrine features.
  • Patients should have recovered from the serious side effects of prior therapies.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Daniel Danila at 646-422-4612.

Disease(s)
Prostate Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
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