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Clinical Trial DRUG CX-839-003

Title
A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients with Relapsed and/or Treatment-Refractory Leukemia
Principal Investigator
Olga Frankfurt
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG CX-839-003
Purpose
The purpose of this study is to evaluate the safety of an investigational drug, CB-839, and to determine the best dose to use for future studies.
Overview
Leukemia (blood cell cancer) begins in the bone marrow, which is a blood-forming tissue, and causes the abnormal growth of blood cells. Leukemia may become active after having previously responded to treatment (relapsed) and/or does not respond to standard treatment (refractory). When this happens there are limited treatment options. The medical and scientific communities are always exploring new ways to treat these cancers. CB-839 is an investigational drug, which means it has not been approved by the United States Food and Drug Administration (FDA) for use outside of clinical studies. This trial will evaluate how well this drug works on relapsed and/or refractory leukemia and study the side effects to decide the highest dose that can be given safely.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years of age or older.
  • Participants must have relapsed or refractory leukemia.
  • Participants with acute promyelocytic leukemia (APL) are not included in this study.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
There are 2 parts to this study. Part 1 is called Dose Escalation. Part 2 is called Dose Expansion. CB-839 is taken orally (by mouth). The study doctor will tell participants what part they will be in and let them know the dosage of CB-839 they will receive. The amount of drug that will be given may vary. The dose is based on when a participant starts the study and what side effects, good and/or bad, have been seen.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 21-Dec-14 06:03 AM

 

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