A Phase I Study of AT13387 Alone or with Abiraterone to Treat Castration-Resistant Prostate Cancer that Continues Growing Despite Abiraterone

Protocol
12-248
Full Title
A Study of HSP90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) No Longer Responding to Abiraterone
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.

Abiraterone acetate is a standard treatment prescribed for men with castration-resistant prostate cancer, but often the cancer eventually continues to grow. In this study, researchers are finding the highest dose of an investigational drug called AT13387 that can be given safely in men with castration-resistant prostate cancer that continues to grow despite abiraterone therapy. In the second part of the study, researchers will evaluate the safety and preliminary effectiveness of AT13387 when combined with abiraterone and steroids in men for whom abiraterone therapy is starting to fail.

AT13387 is designed to inhibit cancer cell growth by blocking HSP90, a protein required for cell growth. It is given intravenously (by vein); abiraterone is given 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 castration-resistant prostate cancer that continues to grow despite abiraterone therapy.
  • Patients must have evidence of disease progression and a serum testosterone level under 50 ng/dL.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients may not have received prior therapy with an HSP90 inhibitor.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Susan F. Slovin at 646-422-4470.

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