Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02071862 · ClinicalTrials.gov registry record · Phase 1
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
A Phase 1 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
NCT02071862 is a Phase 1 study that has completed, run by Calithera Biosciences. The registered enrollment target is 210 participants.
The verdict
NCT02071862, a Phase 1 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 210 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 solid tumors. This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally twice or three times daily. In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors. As an extension of Parts 1 \& 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839. All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug)
Interventions
- DRUG CBD
- DRUG CB-839
- DRUG Pac-CB
- DRUG CBE
- DRUG CB-Erl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2014-02 |
| Est. Completion | 2019-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071862
The ClinicalTrials.gov registry entry for NCT02071862 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 210 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 5 interventions - of which CBD is the first listed.
NCT02071862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02071862 about?
NCT02071862 is a clinical study titled "Study of the Glutaminase Inhibitor CB-839 in Solid 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 NCT02071862?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2014-02. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02071862?
The interventions under investigation include: CBD (DRUG), CB-839 (DRUG), Pac-CB (DRUG), CBE (DRUG), CB-Erl (DRUG).
Who is sponsoring clinical trial NCT02071862?
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.