Colorectal CancerPhase 1/2NCT03263429
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 1/2 study testing Glutaminase Inhibitor CB-839, Panitumumab and Irinotecan Hydrochloride (phase I only) in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastatic Colorectal Cancer, RAS Wild Type Colorectal Cancer
- What is being tested?
- Glutaminase Inhibitor CB-839, Panitumumab and Irinotecan Hydrochloride (phase I only)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 21 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent
- Histologically or cytologically-confirmed diagnosis of metastatic KRAS wildtype colorectal cancer (CRC)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- In dose escalation, patients must have had at least one prior line of chemotherapy for advanced disease or progressed within 6 months of adjuvant therapy (prior chemotherapy and/or anti-EGFR therapy is permitted)
- In dose expansion, patients must have received prior anti-EGFR therapy and achieved at least stable disease on at least one scan as their best response
- In dose expansion, patients must be willing to undergo a pre-treatment biopsy, and four research PET imaging techniques (11C-Glutamine and 18F-FSPG), two pre-treatment and two after one cycle of treatment
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- In dose expansion, at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 which can be followed by CT or magnetic resonance imaging (MRI)
- Absolute neutrophil count (ANC) >= 1,500/uL
- Platelets >= 100,000/uL
- Serum albumin >= 3.0 g/dL
- Serum creatinine =< 2 mg/dL, or calculated creatinine clearance > 50 mL/min (per the Cockcroft-Gault formula)
- Total bilirubin =< 1.5 times upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine aminotransferase (ALT) =< 5.0 x ULN
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 14 days prior to receiving first dose of protocol-indicated treatment; and additionally agree to use at least 2 methods of acceptable contraception or abstain from heterosexual intercourse from the time of signing consent, and until 2 months after patient's last dose of protocol-indicated treatment; WOCBP of childbearing potential are defined as those not surgically sterile or not post-menopausal (i.e. if a female patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrheic for 12 months in the absence of an alternative medical cause, then patient will be considered a female of childbearing potential); postmenopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women
- Men able to father children who are sexually active with WOCBP must agree to use at least 2 methods of acceptable contraception from the time of signing consent and until 2 months after patient's last dose of protocol-indicated treatment; men able to father children are defined as those who are not surgically sterile (i.e. patient has not had a vasectomy)
Who cannot join
- Within 28 days before first dose of protocol-indicated treatment:
- Anti-cancer treatment including chemotherapy, radiation, hormonal therapy, targeted therapy, immunotherapy, or biological therapy
- Major surgery requiring general anesthesia; (Note: within this time frame, placement of a central line or portacath is acceptable and does not exclude)
- Receipt of an investigational agent
- Within 14 days before first dose of protocol-indicated treatment:
- Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics initiated at least 14 days prior to initiation of protocol-indicated treatment are not excluded (e.g. urinary tract infection controlled with antibiotics)
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- Dose escalation only: known grade 4 toxicity probably or definitely attributed to past irinotecan treatment
- Active inflammatory bowel disease, other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day), or bowel obstruction
- History of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
- Unable to receive oral medication
- Central nervous system (CNS) metastasis, unless asymptomatic or previously treated and stable; and no evidence of CNS progression for at least 30 days prior to initiating protocol-indicated treatment; anticonvulsant and/or corticosteroid therapy will be allowed if patient is on a stable or decreasing dose of such treatment for at least 30 days prior to initiating protocol-indicated treatment
- Patients with known Gilbert's disease
- Patient is pregnant or breastfeeding
- Current or previous malignant disease (other than colorectal cancer) within the last 5 years; with the exception of the following if considered curatively treated: non-melanoma skin cancer(s), carcinoma in situ of the cervix, and ductal carcinoma in situ; subjects with another active malignancy requiring concurrent anti-cancer intervention are excluded; (Note the following does not exclude: effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured AND no additional anti-cancer therapy is ongoing and required during the study period)
- Known positive test for human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis A, hepatitis B, hepatitis C, or cytomegalovirus (CMV)
- Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the patient's study physician to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with scheduled visits, treatment schedule, laboratory tests and other study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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
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.
Read the detailed description
Objectives:
Primary Objective of Phase I:
- Determine the safety and tolerability of CB-839 in combination with panitumumab and irinotecan.
Exploratory Objective of Phase I (Optional Imaging Sub-study):
- Correlate radiological features of pre- and post-treatment 11C-Glutamine PET/CT and 18F-FSPG PET/CT with clinical outcome.
Primary Objective of Phase II:
- Determine the efficacy of CB-839 in combination with panitumumab as measured by the response rate (RR).
Secondary Objectives of Phase II:
- Determine the disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
- Perform the following correlative studies (in the phase 2 component):
- Correlate radiological features of pre- and post-treatment 18F-FSPG PET/CT with clinical outcome and biological correlates (tissue gene signature, exosomes).
- Collect blood samples during each radiotracer injection to assess pharmacokinetics.
- Collect pre-treatment biopsy tissue and prospectively correlate clinical outcome with a glutamine metabolism gene signature.
- Quantify exosomal content in the plasma.
Exploratory Objective of Phase II:
- Development of patient-derived organoids from pre-treatment tissue biopsy
OUTLINE: Phase I is a dose-escalation study of glutaminase inhibitor CB-839 in combination with standard doses of panitumumab and irinotecan hydrochloride. Phase II will study efficacy of glutaminase inhibitor CB-839 in combination with standard doses of panitumumab.
Patients receive glutaminase inhibitor CB-839 orally (PO) twice daily (BID) on days 1-28, panitumumab intravenously (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.
After completion of study treatment, patients are followed at 28 days and then every 3 months for up to 1 year.
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer, RAS Wild Type Colorectal Cancer, Refractory Colorectal Cancer
- Being tested
- Glutaminase Inhibitor CB-839, Panitumumab, Irinotecan Hydrochloride (phase I only), Laboratory Biomarker Analysis, Pharmacological Study
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Panitumumab/Irinotecan/CB-839 | Experimental | 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. Receives: Drug: Glutaminase Inhibitor CB-839; Biological: Panitumumab; Drug: Irinotecan Hydrochloride (phase I only); Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Device: Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (Phase I) of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride
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.
Measured: Up to 12 months
Response Rate (Phase II)
The percent of patients with best response as complete response (CR) and partial response(PR) among patients with evaluable result. The response criteria: CR, Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression); Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Up to 12 months
Recommended Phase 2 Dose of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride (Phase I)
The recommended phase 2 dose will be determined.
Measured: Up to 12 months.
Secondary outcomes (5)
Disease Control Rate
The disease control rate will be evaluated. It is defined as the percent of patients with response as CR, PR, or SD among patients with evaluable result. The response criteria: CR, Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression); Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Up to 12 months
Coefficient of Determination (R2) of Maximum Standardized Uptake Value (SUVmax) of Fluorine F 18 L-glutamate Derivative BAY94-9392 (18F-FSPG) Uptake Change With Tumor Size Change (Phase II)
Evaluate the relationship between 18F-FSPG uptake change from baseline and change in tumor size at the time of objective response assessment using a standard linear regression analysis. The coefficient of determination (R2) describes the strength of the relationship between the change in 18F-FSPG and the change in tumor size. The squared root of R2 is the correation coefficient between the change in 18F-FSPG and the change in tumor size. R2 is reported.
Measured: Up to 8 weeks
Plasma Exosomal Content (Phase II)
Plasma exosomal content will be assessed at pre-treatment, after one cycle of treatment, and at disease progression.
Measured: Up to 12 months
Progression Free Survival (Phase II)
It is defined as the time from on treatment to disease progression or death (whichever comes first). For those alive without progression, they were censored at last follow up date. Kaplan-Meier method was used to estimate the median survival time with 95% confidence interval.
Measured: Up to 12 months
Overall Survival
It is defined as the days from on treatment date to death due to any cause. Those alive were censored at the last date of follow up. Kaplan-Meier method was used to estimate the median survival time with 95% confidence interval.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start23 Aug 2017
- Primary completion15 Aug 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Calithera Biosciences, Inc
- Responsible party
- Principal investigator, Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Jordan Berlin, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263429
- Sponsor's protocol ID
- VICC GI 1703
- Other IDs
- NCI-2017-01461
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2017
- Last updated
- 30 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03263429
- Acronym / sponsor ID
- VICC GI 1703
- Conditions
- Colorectal Cancer, Metastatic Colorectal Cancer, RAS Wild Type Colorectal Cancer, Refractory Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Calithera Biosciences, Inc
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Posted 30 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary Objective of Phase I:
- Determine the safety and tolerability of CB-839 in combination with panitumumab and irinotecan.
Exploratory Objective of Phase I (Optional Imaging Sub-study):
- Correlate radiological features of pre- and post-treatment 11C-Glutamine PET/CT and 18F-FSPG PET/CT with clinical outcome.
Primary Objective of Phase II:
- Determine the efficacy of CB-839 in combination with panitumumab as measured by the response rate (RR).
Secondary Objectives of Phase II:
- Determine the disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
- Perform the following correlative studies (in the phase 2 component):
- Correlate radiological features of pre- and post-treatment 18F-FSPG PET/CT with clinical outcome and biological correlates (tissue gene signature, exosomes).
- Collect blood samples during each radiotracer injection to assess pharmacokinetics.
- Collect pre-treatment biopsy tissue and prospectively correlate clinical outcome with a glutamine metabolism gene signature.
- Quantify exosomal content in the plasma.
Exploratory Objective of Phase II:
- Development of patient-derived organoids from pre-treatment tissue biopsy
OUTLINE: Phase I is a dose-escalation study of glutaminase inhibitor CB-839 in combination with standard doses of panitumumab and irinotecan hydrochloride. Phase II will study efficacy of glutaminase inhibitor CB-839 in combination with standard doses of panitumumab.
Patients receive glutaminase inhibitor CB-839 orally (PO) twice daily (BID) on days 1-28, panitumumab intravenously (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.
After completion of study treatment, patients are followed at 28 days and then every 3 months for up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Panitumumab/Irinotecan/CB-839 | Experimental | Drug: Glutaminase Inhibitor CB-839, Biological: Panitumumab, Drug: Irinotecan Hydrochloride (phase I only), Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Device: Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scansPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed and dated written informed consent
- Histologically or cytologically-confirmed diagnosis of metastatic KRAS wildtype colorectal cancer (CRC)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- In dose escalation, patients must have had at least one prior line of chemotherapy for advanced disease or progressed within 6 months of adjuvant therapy (prior chemotherapy and/or anti-EGFR therapy is permitted)
- In dose expansion, patients must have received prior anti-EGFR therapy and achieved at least stable disease on at least one scan as their best response
Key exclusion criteria (16 listed)
- Within 28 days before first dose of protocol-indicated treatment:
- Within 14 days before first dose of protocol-indicated treatment:
- Dose escalation only: known grade 4 toxicity probably or definitely attributed to past irinotecan treatment
- Active inflammatory bowel disease, other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day), or bowel obstruction
- History of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutaminase Inhibitor CB-839Given by mouth | Drug | Panitumumab/Irinotecan/CB-839 |
| PanitumumabGiven by vein | Biological | Panitumumab/Irinotecan/CB-839 |
| Irinotecan Hydrochloride (phase I only)Given by vein | Drug | Panitumumab/Irinotecan/CB-839 |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Panitumumab/Irinotecan/CB-839 |
| Pharmacological StudyCorrelative studies | Other | Panitumumab/Irinotecan/CB-839 |
| Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scansDuring phase II at baseline and day 28 of cycle 1 | Device | Panitumumab/Irinotecan/CB-839 |
Primary outcome
Maximum Tolerated Dose (Phase I) of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride
Time frame: Up to 12 months
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.
Response Rate (Phase II)
Time frame: Up to 12 months
The percent of patients with best response as complete response (CR) and partial response(PR) among patients with evaluable result. The response criteria: CR, Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR, At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Progressive Disease (PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression); Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Recommended Phase 2 Dose of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride (Phase I)
Time frame: Up to 12 months.
The recommended phase 2 dose will be determined.
5 secondary outcomes
Disease Control Rate
Time frame: Up to 12 months
Coefficient of Determination (R2) of Maximum Standardized Uptake Value (SUVmax) of Fluorine F 18 L-glutamate Derivative BAY94-9392 (18F-FSPG) Uptake Change With Tumor Size Change (Phase II)
Time frame: Up to 8 weeks
Plasma Exosomal Content (Phase II)
Time frame: Up to 12 months
Progression Free Survival (Phase II)
Time frame: Up to 12 months
Overall Survival
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Berlin, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glutaminase Inhibitor CB-839, Panitumumab and Irinotecan Hydrochloride (phase I only) in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (Phase I) of CB-839 in Combination With Panitumumab and Irinotecan Hydrochloride (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.