A Phase II Study of MLN0128 in Men with Castration-Resistant Prostate Cancer

Full Title

A Phase 2 Study of the Dual mTOR Inhibitor MLN0128 in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC)

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). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers.”

The purpose of this study is to assess the safety and effectiveness of an investigational drug called MLN0128 (formerly known as INK128) in men with castration-resistant prostate cancer that has continued to grow despite chemotherapy. MLN0128 works by blocking a molecular signaling pathway called mTOR that is overactive in some cancers. It is a capsule that is taken orally (by mouth).

Eligibility

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

  • Patients must have castration-resistant prostate cancer that has continued to grow despite chemotherapy.
  • Patients must have received therapy with enzalutamide and/or abiraterone before entering the study.
  • At least 4 weeks must pass between the completion of prior therapies (8 weeks for radioisotopes and immunotherapies) and entry into the study.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.

Protocol

13-143

Phase

II

Investigator

Co-Investigators

Locations