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NCT03263429 · ClinicalTrials.gov registry record · Phase 1
Novel PET/CT Imaging Biomarkers of CB-839 in Combination With Panitumumab and Irinotecan in Patients With Metastatic and Refractory RAS Wildtype Colorectal Cancer
A Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT03263429: Completed Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT03263429 is a Phase 1 study that has completed, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03263429, a Phase 1 study, has completed, sponsored by Vanderbilt-Ingram Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This phase I/II trial studies the best dose and side effects of glutaminase inhibitor CB-839 and how well it works with panitumumab and irinotecan hydrochloride (phase I only) in treating patients with RAS wildtype colorectal cancer that has spread to other places in the body and does not respond to treatment. Glutaminase inhibitor CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving glutaminase inhibitor CB-839 with panitumumab and irinotecan hydrochloride may work better in treating patients with colorectal cancer.
Primary Outcome
The maximum tolerated dose of CB-839 will be determined in Phase I with dose-escalation following Bayesian continual reassessment method. Patients were treated in cohort of 3. The CB839 dose leves were 400, 600 and 800mg.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Panitumumab
- OTHER Pharmacological Study
- DRUG Glutaminase Inhibitor CB-839
- DRUG Irinotecan Hydrochloride (phase I only)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2023-12-21 |
| Phase | Phase 1 |
What the finished NCT03263429 record still lists
NCT03263429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03263429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03263429 about?
NCT03263429 is a clinical study titled "Novel PET/CT Imaging Biomarkers of CB-839 in Combination With Panitumumab and Irinotecan in Patients With Metastatic and Refractory RAS Wildtype Colorectal Cancer". This phase I/II trial studies the best dose and side effects of glutaminase inhibitor CB-839 and how well it works with panitumumab and irinotecan hydrochloride (phase I only) in treating patients with RAS wildtype colorectal cancer that has spread to other places in the body and does not respond to...
What is the current status of trial NCT03263429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2017-08-23. Estimated completion is 2023-12-21.
What interventions are being tested in trial NCT03263429?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Panitumumab (BIOLOGICAL), Pharmacological Study (OTHER), Glutaminase Inhibitor CB-839 (DRUG), Irinotecan Hydrochloride (phase I only) (DRUG).
Who is sponsoring clinical trial NCT03263429?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03263429's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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