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Fatty Acid Synthase Inhibitor

TVB-2640 for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Led By David Gerber, MD
Research Sponsored by David E Gerber
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic or advanced stage, histologically or cytologically confirmed NSCLC and molecular identification of oncogenic KRAS mutation.
KRAS mutant NSCLC must be refractory, relapsed, and previously treated with doublet chemotherapy and immune checkpoint inhibitor (unless there is a specific contraindication to checkpoint inhibitor).
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upevery 8 weeks through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test a new cancer drug, TVB-2640, on patients with a specific type of non-small cell lung cancer.

Eligible Conditions
  • KRAS Gene Mutation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control rate of TVB-2640
Response rate of TVB-2640
Secondary outcome measures
Establish the predictive value of 11C-acetate PET
Mean change in fasting plasma lipidomics
Mean change in sebaceous secretion of fatty acids
+1 more

Side effects data

From 2021 Phase 2 trial • 25 Patients • NCT03032484
78%
Palmar plantar erythrodysesthesia syndrome
65%
Mucositis
57%
Hypertension
52%
Dry Eye
30%
Fatigue
22%
Skin infection
22%
Muscle weakness
22%
alopecia
17%
Arthralgia
17%
Myalgia
13%
Elevated ALT/AST
13%
Allergic rhinitis
13%
Constipation
13%
Parestheisa
13%
Hoarseness
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TVB-2640Experimental Treatment1 Intervention
Patients will be administered TVB-2640 100mg/m2 orally once a day for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TVB-2640
2019
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
49 Previous Clinical Trials
98,239 Total Patients Enrolled
David E GerberLead Sponsor
Sagimet Biosciences Inc.Industry Sponsor
7 Previous Clinical Trials
582 Total Patients Enrolled

Media Library

TVB-2640 (Fatty Acid Synthase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03808558 — Phase 2
KRAS Mutation Research Study Groups: TVB-2640
KRAS Mutation Clinical Trial 2023: TVB-2640 Highlights & Side Effects. Trial Name: NCT03808558 — Phase 2
TVB-2640 (Fatty Acid Synthase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808558 — Phase 2

Frequently Asked Questions

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

What are the goals that researchers hope to achieve with this clinical trial?

"The main goal of this trial is to assess the disease control rate of TVB-2640 over the course of a year. Secondary objectives include assessing the mean change in sebaceous secretion of fatty acids, safety profile of TVB-2640, and mean change in fasting plasma lipidomics."

Answered by AI

How many people are taking part in this clinical trial?

"That is correct, the clinical trial is still looking for patients. The public information on the website was first posted on September 11th, 2019 and updated February 3rd, 2022. At this time, they are enrolling 12 individuals between 2 locations."

Answered by AI

Are people with the relevant medical condition able to participate in this trial currently?

"That is correct, the online clinicaltrials.gov database has information stating that this trial is still recruiting patients. The 12 subjects needed for this study are being recruited from 2 medical facilities, and the trial was first posted on September 11th, 2019 with its most recent edit on February 3rd, 2022."

Answered by AI

Is TVB-2640 able to be legally prescribed by doctors in the United States?

"TVB-2640 is currently in Phase 2 of clinical trials. While there is some evidence supporting its safety, there is none yet to suggest that it is an effective medication."

Answered by AI
~7 spots leftby Dec 2024