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Fatty Acid Synthase Inhibitor
TVB-2640 for Colon Cancer
Phase 1
Recruiting
Led By Mark B Evers, MD
Research Sponsored by Mark Evers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of study drug and currently has adequate cardiac function, as evidenced by a left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO); and corrected QT interval (QTc) < 470 msec
Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 days
Awards & highlights
Study Summary
This trialwill evaluate the effects of a drug, TVB-2640, on cancer cells and metabolic endpoints to determine if it could be used to treat resectable cancers.
Who is the study for?
This trial is for adults with confirmed, resectable colon cancer without distant metastases. Participants must be able to perform daily activities (ECOG status 0 or 1), have good bone marrow function and cardiac health, not have received recent cancer treatments, and agree to use contraception. Those with significant heart disease, GI absorption issues, psychiatric disorders that affect compliance, pregnancy or breastfeeding are excluded.Check my eligibility
What is being tested?
The study tests TVB-2640's effects on metabolic endpoints in tumor tissues of patients with resectable cancers. It aims to see if the drug reduces cancer cell growth and affects cell survival signals and lipid creation by comparing it against a placebo in short-term treatment before surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include typical reactions related to metabolism-altering drugs such as gastrointestinal disturbances, changes in blood sugar levels or liver enzymes. Close monitoring during the trial will help identify any adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is healthy, with no recent heart attacks and normal heart function tests.
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I can do most of my daily activities but may struggle with very hard tasks.
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My colon cancer can be removed by surgery and has not spread to distant parts of my body.
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I am 18 years old or older.
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My blood tests show normal levels of hemoglobin, ANC, and platelets.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Carnitine
Secondary outcome measures
Comprehensive profile of cellular metabolites involved in various pathways (glycolysis, PPP, Krebs cycle, glutaminolysis) will be assessed in the post-treatment tumor samples using mass spectrometry analyses.
Expression of markers of tumor growth and cell proliferation (Ki67, β-catenin, c-Myc, survivin, p-AKT, etc) in the pre- treatment (where available) and post-treatment tumor samples will be evaluated using IHC
FASN levels in the pre-treatment and post-treatment tumor samples will be evaluated using IHCsamples will be evaluated using IHC.
+4 moreSide effects data
From 2021 Phase 2 trial • 25 Patients • NCT0303248478%
Palmar plantar erythrodysesthesia syndrome
65%
Mucositis
57%
Hypertension
52%
Dry Eye
30%
Fatigue
22%
Muscle weakness
22%
alopecia
22%
Skin infection
17%
Arthralgia
17%
Myalgia
13%
Allergic rhinitis
13%
Constipation
13%
Hoarseness
13%
Parestheisa
13%
Elevated ALT/AST
13%
Headache
13%
Depression
13%
Dysphasia
9%
Upper respiratory tract infection
9%
Urinary Tract Infection
9%
Cognitive Disturbance
9%
Conjunctivitis
9%
Diarrhea
9%
Dry Mouth
9%
Dry Skin
9%
Limb edema
9%
Hypokalemia
9%
Pruritis
4%
Acute kidney injury
4%
Anorexia
4%
Aphasia
4%
Bronchitis
4%
Confusion
4%
Increased Creatinine
4%
Thromboembolic event
4%
Vomiting
4%
Wound infection
4%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab and TVB-2640
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TVB-2640Experimental Treatment1 Intervention
TVB-2640 is a potent and reversible inhibitor of the FASN enzyme.
Group II: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640
2019
Completed Phase 2
~550
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Mark EversLead Sponsor
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,084 Total Patients Enrolled
Mark B Evers, MDPrincipal InvestigatorLucille P. Markey Cancer Center at University of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart is healthy, with no recent heart attacks and normal heart function tests.I have risk factors for a specific heart rhythm problem but can take certain medications.I can do most of my daily activities but may struggle with very hard tasks.I cannot take pills by mouth or have a stomach condition that affects medication absorption.I haven't had any cancer treatment or experimental drugs in the last 4 to 6 weeks.I am 18 years old or older.My blood tests show normal levels of hemoglobin, ANC, and platelets.My colon cancer can be removed by surgery and has not spread to distant parts of my body.I am a male and will use birth control during and for 3 months after the study, or I am sterile.I have significant dry eye or corneal issues, or I won't stop wearing contacts during the study.I cannot have surgery due to other health issues.I am using or willing to use two birth control methods, or I am not able to have children.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: TVB-2640
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible dangers could arise from administering TVB-2640 to patients?
"As TVB-2640 is undergoing Phase 1 trials, there is not yet much clinical data available to back its safety or efficacy. Our team has therefore assigned it a score of 1 on the risk scale."
Answered by AI
Could elderly individuals beyond the age of 80 participate in this experiment?
"According to the inclusion criteria listed, this trial is open to participants aged 18-99. Additionally, there are 7 studies tailored for those under 18 and 240 clinical trials targeting patients over 65."
Answered by AI
Are there any available opportunities for participants in this investigation?
"According to the data on clinicaltrials.gov, this investigation is currently recruiting participants; initial postings were published in October 2017 and last updated a year ago."
Answered by AI
Could I potentially become a participant of this experiment?
"This experiment is recruiting 48 individuals aged 18-99 with a malignant colon neoplasm. The primary eligibility requirements consist of: histologically or cytologically confirmed, resectable cancer without metastasis; willingness to sign the informed consent form prior to any trial procedures; male/female over the age of 18 years old; hemoglobin and platelet levels >= 9 g/dL & 100 x 109/L respectively; no major heart conditions within 6 months preceeding drug administration as evidenced by MUGA or ECHO, QTc < 470 msec ; all females must use 2 forms of birth control throughout the duration of study ("
Answered by AI
How many individuals have volunteered to take part in this medical experiment?
"Affirmative. Clinicaltrials.gov's records show that this research, which was initially posted on October 6th 2017, is now recruiting participants. The study needs 48 people to join from one location."
Answered by AI
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