Novel PET/CT Imaging Biomarkers of CB-839 in Combination With Panitumumab and Irinotecan in Patients With Metastatic and Refractory RAS Wildtype Colorectal Cancer

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT03263429
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Colorectal Cancer
  • Metastatic Colorectal Cancer
  • RAS Wild Type Colorectal Cancer
  • Refractory Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glutaminase Inhibitor CB-839 — DRUG
    Given by mouth
  • Panitumumab — BIOLOGICAL
    Given by vein
  • Irinotecan Hydrochloride (phase I only) — DRUG
    Given by vein
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scans — DEVICE
    During phase II at baseline and day 28 of cycle 1

Study Details

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.

Key Dates

Start date
Aug 23, 2017
Status verified
Aug 2024
Primary completion
Aug 15, 2023
Completion
Dec 21, 2023

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Panitumumab/Irinotecan/CB-839
    Patients receive glutaminase inhibitor CB-839 PO BID on days 1-28, panitumumab IV over 60-90 minutes on days 1 and 15, and irinotecan hydrochloride IV over 90 minutes on day 1 and 15 (Phase I only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (Phase I) of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Nashville, TN

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TN

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