A Phase I Study of CC-90011 Alone and with Abiraterone/Prednisone in Men with Metastatic Castration-Resistant Prostate Cancer

Share
Print

Full Title

A Phase 1, Open-Label, Functional Imaging Study to Assess Whether CC-90011 Reverses the Castration Resistance Due to Lineage Switch in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Have Failed Enzalutamide as Last Prior Therapy, Followed by a Dose Finding Study of CC-90011 Combined with Abiraterone and Prednisone

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). 

The investigational drug CC-90011 may prevent or reverse the development of the resistance that prostate cancer cells can develop to hormone therapies. In this study, researchers are assessing the safety of CC-90011 when given alone in men with CRPC, and then in combination with abiraterone and prednisone, two drugs which are already used as standard hormone therapy for CRPC. They will see if CC-90011 causes changes in tumor cells that may help the cancer respond better to abiraterone and prednisone. All three medications 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 CRPC that continues to grow despite enzalutamide therapy which was completed at least 30 days before receiving the study treatment.
  • Any other anticancer treatments must have been completed at least 4 weeks earlier.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and 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 patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Morris at 646-422-4469.

Protocol

21-083

Phase

I

Investigator

Co-Investigators