A Phase Ib Study of ARN-509 plus Everolimus in Men with Progressive Metastatic Castration-Resistant Prostate Cancer After Abiraterone Therapy

Protocol
13-025
Full Title
Phase 1b Study of ARN 509 Plus Everolimus in Men with Progressive Metastatic Castration-Resistant Prostate Cancer After Treatment with Abiraterone Acetate
Phase
I
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 androgen receptor is a protein that is important in the development and progression of prostate cancer. ARN-509 is an investigational drug designed to inhibit prostate cancer growth by blocking the androgen receptor. It is being evaluated in studies of men with castration-resistant prostate cancer that has spread (metastasized) to other parts of the body.

In this study, researchers are evaluating ARN-509 with the drug everolimus in men with castration-resistant prostate cancer that has continued to grow after treatment with abiraterone acetate. Everolimus inhibits a molecule called mTOR, which helps cancer cells grow. It is approved for treating others cancers, such as kidney cancer, but its use in this study is considered investigational. Both ARN-509 and everolimus 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 castration-resistant prostate cancer that continued to grow despite at least six months of treatment with abiraterone acetate.
  • At least 4 weeks must pass since completing abiraterone treatment and entering the study.
  • Patients must recover from the serious side effects of therapy before entering 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.

Disease(s)
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
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