A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

Study Status

Open to Enrollment

Study Description

This clinical trial is for men with metastatic castrate resistant prostate cancer and neuroendocrine prostate cancer.

The purpose of the study is to evaluate how well men with neuroendocrine prostate cancer respond to treatment with the experimental drug MLN8237.

MLN8237 (also called alisertib) is a pill taken by mouth. It has been developed to interfere with cell division, which is required for cancer cell growth. Aurora A kinase is an enzyme that may have a role in the progression of prostate cancer to neuroendocrine prostate cancer, which tends to behave aggressively and not respond well to most other therapies used for advanced prostate cancer. MLN8237 works by blocking Aurora A kinase. This may interfere with dividing cells, thereby slowing the growth of cancer and killing cancer cells.

All study participants will receive MLN8237; there is no placebo used in this study.  Participants will take MLN8237 in 21-day cycles:

  •  MLN8237 twice a day for 7 days in a row; after the 7 days of treatment, will not take it again for 2 weeks and then restart the cycle again

Study participants will continue with MLN8237 therapy as long as they are responding to treatment and not experiencing unacceptable side effects. 

Sponsor

Weill Cornell Medical College

Key Eligibility

  • Men age 18 and older
  • Metastatic neuroendocrine prostate cancer
  • Have had surgical or ongoing chemical castration (men with pure small cell neuroendocrine prostate cancer are not required to have received androgen deprivation therapy or castrate levels of testosterone)
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Himisha Beltran, MD

Contact


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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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