MedTrace Logo

TVB 2640 for Resectable Colon Cancer Other Resectable Cancers; a Window Trial.

NCT02980029 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-10-22

No results posted yet for this study

Summary

Primary Objective

• To evaluate the pharmacodynamic effects on metabolic endpoints (malonyl carnitine and tripalmitin levels) following short-term treatment with TVB-2640 in patients with resectable cancers

Secondary Objectives

* To determine if short-term treatment with TVB-2640 decreases cancer cell proliferation.
* To examine other biological endpoints and determine if TVB-2640 inhibits cell survival signaling and lipid biogenesis.
* To perform comprehensive metabolomic analysis in tumor tissues to identify metabolic alterations induced by TVB-2640 treatment.
* To correlate FASN levels in tumor with metabolic and biological endpoints to determine if FASN inhibition has more pronounced effects in patients with increased expression.

Conditions

Interventions

DRUG

TVB-2640

TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme. TVB-2640 is uncompetitive towards both NADPH and acetoacetyl-CoA in inhibiting KR activity.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mark Evers

    lead OTHER

Principal Investigators

  • Mark B Evers, MD · Lucille P. Markey Cancer Center at University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2023-10-22
Completion
2023-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02980029 on ClinicalTrials.gov