A Phase IB Study of CC-115 with Enzalutamide in Men with Castration-Resistant Prostate Cancer

Full Title

A Phase 1b Study of Enzalutamide Plus CC-115 in Men with 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" (CRPC).

Enzalutamide is a drug used to treat CRPC. It works by blocking a protein called the androgen receptor. Researchers want to learn if adding the investigational drug CC-115 to enzalutamide treatment is more effective than enzalutamide alone. In this study, they are assessing increasing doses of CC-115 in combination with enzalutamide and observing the anticancer effects of this treatment.

CC-115 is designed to inhibit the growth of cancer cells by blocking an enzyme cancer cells need called DNA-PK and a protein called mTOR. Both CC-115 and enzalutamide are 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 metastatic CRPC with rising PSA or evidence of continued cancer growth.
  • Prior chemotherapy for CRPC and treatment with enzalutamide, abiraterone acetate, mTOR inhibitors, or medications targeting the PI3K/AKT pathway are not permitted.
  • At least 4 weeks must pass between the completion of prior therapies and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men 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

16-074

Phase

I

Investigator

Co-Investigators

Locations