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NCT02071888 · ClinicalTrials.gov registry record · Phase 1
Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
A Phase 1 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT02071888: Completed Phase 1 study, sponsored by Calithera Biosciences.
NCT02071888 is a Phase 1 study that has completed, run by Calithera Biosciences. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02071888, a Phase 1 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 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 advanced hematologic malignancies. This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM) In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). 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. As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.
Interventions
- DRUG CB-839
- DRUG CB-839 and low dose dexamethasone
- DRUG CB-839, pomalidomide, and low dose dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT02071888 record still lists
NCT02071888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which CB-839 is the first listed.
NCT02071888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02071888 about?
NCT02071888 is a clinical study titled "Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors". 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 NCT02071888?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-02. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02071888?
The interventions under investigation include: CB-839 (DRUG), CB-839 and low dose dexamethasone (DRUG), CB-839, pomalidomide, and low dose dexamethasone (DRUG).
Who is sponsoring clinical trial NCT02071888?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02071888's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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