A Phase IA/B Study of CC-115 in Castration-Resistant Prostate Cancer

Protocol
12-080
Full Title
A Phase 1A/1B, Multicenter, Open Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual DNA-PK and TOR Kinase Inhibitor, CC-115, Administered Orally to Subjects with Advanced Solid Tumors and Hematologic Malignancies
Phase
I/II
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 purpose of this study is to find the highest dose of an investigational drug called CC-115 that can be given safely in men with castration-resistant prostate cancer, and to assess its preliminary effectiveness against this cancer. CC-115 works by blocking the activity of two proteins that fuel cancer growth: “mTOR” and “DNA-dependent protein kinase.” CC-115 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 castration-resistant prostate cancer.
  • Patients’ serum testosterone level must be under 50 ng/dL.
  • At least 4 weeks must have passed since completion of hormonal therapies and corticosteroids and 6 weeks since the last dose of finasteride, bicalutamide, and nilutamide 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 open to patients 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
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases

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