Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02071927 · ClinicalTrials.gov registry record · Phase 1
Study of the Glutaminase Inhibitor CB-839 in Leukemia
A Phase 1 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02071927 is a Phase 1 study that has completed, run by Calithera Biosciences. The registered enrollment target is 43 participants.
The verdict
NCT02071927, a Phase 1 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with leukemia. This study is an open-label Phase 1 evaluation of CB-839 in subjects with leukemia. Part 1 is a dose escalation study to identify the recommended Phase 2 dose as a single agent and in combination with azacitidine. Patients enrolled into Part 2 will be treated with the recommended Phase 2 dose. As an extension of Part 2, patients with relapsed/ refractory or newly diagnosed AML will be treated with CB-839 in combination with azacitidine. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.
Interventions
- DRUG CB-839
- DRUG CB-Aza
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071927
The ClinicalTrials.gov registry entry for NCT02071927 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calithera Biosciences, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CB-839 is the first listed.
NCT02071927 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02071927 about?
NCT02071927 is a clinical study titled "Study of the Glutaminase Inhibitor CB-839 in Leukemia". Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be ...
What is the current status of trial NCT02071927?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2014-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02071927?
The interventions under investigation include: CB-839 (DRUG), CB-Aza (DRUG).
Who is sponsoring clinical trial NCT02071927?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.