A Phase I Study of CC-94676 in Men with Metastatic Castration-Resistant Prostate Cancer

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Full Title

A Phase 1, Multi-Center, Open-Label, Dose Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-94676 in Subjects with Metastatic Castration-Resistant Prostate Cancer

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 androgen receptor is a protein that is important in the development and progression of prostate cancer. CC-94676 is an investigational drug designed to inhibit prostate cancer growth by blocking the androgen receptor.

In this study, researchers are finding the highest dose of CC-94676 that can be given safely in men with metastatic CRPC. CC-94676 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 metastatic CRPC that continues to grow despite abiraterone, enzalutamide, apalutamide, or darolutamide as well as taxane chemotherapy (or cannot be treated with chemotherapy).
  • At least 4 weeks must pass between 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 ages 18 and older.

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

Protocol

20-479

Phase

I

Investigator

Co-Investigators