A Phase I Study of CB-839 in Patients with Advanced or Persistent Hematologic Cancers

Protocol
14-053
Full Title
A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Advanced and/or Treatment-Refractory Hematological Malignancies
Phase
I
Purpose

The standard treatments for non-Hodgkin lymphoma (NHL), multiple myeloma, and Waldenstrom’s macroglobulinemia (WM) include radiation therapy and/or chemotherapy. However, a high percentage of patients don’t respond to therapy or experience a recurrence of their disease. Doctors are therefore seeking more effective treatments.

CB-839 is an investigational drug that works by inhibiting an enzyme involved in cancer metabolism called glutaminase. Glutamine is an important source of energy for many cancer cells. This study will investigate a novel approach to therapy by targeting an important fuel source that has the potential of inhibiting tumor cell growth and survival. Researchers want to find the highest dose of CB-839 that can be given safely in patients with NHL, multiple myeloma, or WM that has continued to grow or has come back despite two or more prior regimens of therapy. CB-839 is a capsule that 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 NHL, multiple myeloma, or WM that has continued to grow or has come back despite two or more prior regimens of therapy.
  • Patients must have recovered from the serious side effects of previous treatments 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 patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Anas Younes at 212-639-5059 or Amy Copeland at 212-639-6104.

Disease(s)
Hematology: Hematologic Malignancies
Hematology: Multiple Myeloma
Lymphoma: Non-Hodgkin's Lymphoma
Locations