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Glutaminase Inhibitor

CB-839 + Panitumumab + Irinotecan for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Jordan Berlin, MD
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine =< 2 mg/dL, or calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing glutaminase inhibitor CB-839 with panitumumab and irinotecan hydrochloride to treat patients with colorectal cancer that has spread and does not respond to treatment.

Who is the study for?
This trial is for adults with metastatic RAS wildtype colorectal cancer that's resistant to treatment. They must be in good physical condition, have certain blood and organ function levels, and not be pregnant or breastfeeding. Participants need to agree to use contraception and some will undergo biopsies and PET scans.Check my eligibility
What is being tested?
The trial tests CB-839 (a glutaminase inhibitor) combined with panitumumab (an antibody) and sometimes irinotecan hydrochloride (chemotherapy). It aims to find the best dose, understand side effects, and see how well these treatments work together against advanced colorectal cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation by monoclonal antibodies like panitumumab, chemotherapy-related issues such as nausea or hair loss from irinotecan hydrochloride, and any unknown risks from the new drug CB-839.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal or only slightly impaired.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My colorectal cancer is confirmed to be KRAS wildtype and has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (Phase I) B-839 in combination with panitumumab and irinotecan hydrochloride
Recommended phase 2 dose of CB-839 in combination with panitumumab and irinotecan hydrochloride (Phase I)
Response rate (Phase II)
Secondary outcome measures
Disease control rate
Maximum Standardized Uptake Value (SUVmax) of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) uptake (Phase II)
Overall Survival
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Panitumumab/Irinotecan/CB-839Experimental Treatment6 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glutaminase Inhibitor CB-839
2017
Completed Phase 2
~30
Panitumumab
2020
Completed Phase 3
~6490

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,904 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,638 Total Patients Enrolled
Calithera Biosciences, IncIndustry Sponsor
33 Previous Clinical Trials
1,992 Total Patients Enrolled

Media Library

CB-839 (Glutaminase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03263429 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Panitumumab/Irinotecan/CB-839
Colorectal Cancer Clinical Trial 2023: CB-839 Highlights & Side Effects. Trial Name: NCT03263429 — Phase 1 & 2
CB-839 (Glutaminase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03263429 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic applications is Glutaminase Inhibitor CB-839 employed for?

"Colorectal carcinoma sufferers often benefit from Glutaminase Inhibitor CB-839. This medication is also effective in treating ovarian cancer, sarcoma, and metastatic colorectal carcinoma."

Answered by AI

What are the principal goals of this exploration?

"Calithera Biosciences, Inc - the study sponsor- has specified that Maximum tolerated dose (Phase I) B-839 in combination with panitumumab and irinotecan hydrochloride will be tracked as a primary outcome over a period of 12 months. Further, secondary outcomes such as Maximum Standardized Uptake Value (SUVmax) of fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG), Disease control rate, and Progression free survival (phase II) will all be assessed. The latter two metrics entail quantifying the"

Answered by AI

What is the participant quota for this research endeavor?

"Affirmative. Information published on clinicaltrials.gov confirms that registration is open for this medical research, which was initially posted in August 2017 and updated at the end of November 2022. A total of 40 participants are being sought from a single site."

Answered by AI

Are there any vacant positions available for participants in this experiment?

"According to the data sourced from clinicaltrials.gov, this investigation is currently recruiting participants that meet its eligibility criteria. The trial was first published on August 23rd 2017 and has since been updated most recently on November 22nd 2022."

Answered by AI

Could you please summarize previous investigations into Glutaminase Inhibitor CB-839?

"At present, there are 54 Phase 3 and 288 open trials studying Glutaminase Inhibitor CB-839. Indeed, a total of 8933 medical facilities worldwide have conducted studies on this inhibitor with the majority located in Woolloongabba, Queensland."

Answered by AI
~4 spots leftby Apr 2025