A Phase I/IIA Study of CORT125281 plus Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

Full Title

Phase 1/2 Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CORT125281 with Enzalutamide in Patients 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).

Enzalutamide is a standard drug used to treat CRPC. It works by blocking a protein called the androgen receptor. Eventually, prostate cancer becomes resistant to enzalutamide as well. One of the causes of resistance to treatment may be through the effects of the stress hormone cortisol, which may cause the tumor to grow. CORT125281 is an investigational drug that inhibits cortisol by blocking the glucocorticoid receptor and may therefore help prevent or overcome resistance to enzalutamide.

In this study, researchers are determining the highest dose of CORT125281 that can be given safely with enzalutamide in men with metastatic CRPC. Both drugs 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 that has continued to grow despite prior treatment.
  • At least 4 weeks must pass between the completion of prior therapy and entry into the study.
  • Patients may not have received more than two previous regimens of chemotherapy.
  • 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 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

18-142

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators