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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 is a Phase 1 study that has completed, run by Calithera Biosciences. The registered enrollment target is 25 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071888
The ClinicalTrials.gov registry entry for NCT02071888 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 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 3 interventions - of which CB-839 is the first listed.
NCT02071888 reports 0 study locations.
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.
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