A Phase I Study of CB-839 in Patients with Advanced Solid Tumors

Protocol
14-111
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 Solid Tumors
Phase
I
Purpose

Glutaminase is an enzyme that makes energy for cancer cells and for the body. CB-839 is an investigational drug designed to block glutaminase. Laboratory studies have shown that it can stop cancer cells from growing, but it does not harm normal cells.

In this study, researchers want to find the highest dose of CB-839 that can be given safely in patients with advanced solid tumors that have continued to grow despite standard therapy or for which no standard therapy exists. CB-839 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 an advanced solid tumor that has continued to grow despite standard therapy or for which no standard therapy exists. Examples include triple-negative breast cancer, non-small cell lung cancer, mesothelioma, renal cell carcinoma, melanoma, head and neck cancer, colorectal cancer, and pancreatic cancer.
  • At least 3 weeks must have passed since the completion of prior therapies and entry into the study, and patients should have recovered from any serious side effects.
  • 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. James J. Harding at 646-888-4314.

Disease(s)
Breast Cancer
Colorectal Cancer
Head & Neck Cancer
Kidney Cancer
Lung Cancer, Non-Small Cell
Melanoma
Mesothelioma
Solid Tumors
Upper Gastrointestinal: Pancreatic Cancer
Locations