CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 29 enrolled
Drug / intervention
Glutaminase Inhibitor CB-839 +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03263429
NCT03263429Phase 2Completed

Phase I/II Study to Evaluate the Safety, Efficacy, and Novel PET/CT Imaging Biomarkers of CB-839 in Combination With Panitumumab and Irinotecan in Patients With Metastatic and Refractory RAS Wildtype Colorectal Cancer

Vanderbilt-Ingram Cancer Center·interventional·Posted Aug 28, 2017·Updated Aug 30, 2024

In Brief

A Phase 2 clinical trial evaluating Glutaminase Inhibitor CB-839, Panitumumab, and 4 other interventions for Colorectal Cancer and 3 related conditions. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 28, 2017
Enrollment StartAug 23, 2017
Primary CompletionAug 15, 2023
Study CompletionDec 21, 2023
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.8 years ago

Interventions

Glutaminase Inhibitor CB-839drug

Given by mouth

Panitumumabbiological

Given by vein

Irinotecan Hydrochloride (phase I only)drug

Given by vein

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scansdevice

During phase II at baseline and day 28 of cycle 1