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

Colon Cancer Clinical Trial

Official title: Pharmacodynamic Effects of Fatty Acid Synthase (FASN) Inhibition With TVB-2640 in Resectable Colon Cancer and Other Resectable Cancers; a Window Trial.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study will test the hypothesis that inhibition of FASN activity blocks tumor lipid biosynthesis and alters the cellular metabolism in colon and other resectable cancers.

• The study is a randomized, double-blind, placebo-controlled pharmacodynamic study.

• Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics. Eligible patients with histologically or cytologically confirmed resectable cancers without any distant metastases will be identified. Upon obtaining informed consent, patients will be enrolled into the study and randomized to TVB-2640 or placebo in a 2:1 fashion. Subjects and clinical investigators will be blinded to treatment group assignment.

• Baseline blood samples will be collected on Day 0 for all patients.

• All enrolled patients will receive the study drug (TVB-2640 or placebo) at a BSA-derived flat dose, orally once daily, starting Day 1. They will receive the study drug for 10-21 days (minimum of 10 days and a maximum of 21 days), i.e. from Day 1 to Day 10-21. The last dose of the study drug will be on the day before the surgical resection.

• For patients in both randomization groups, surgery will be performed anytime during the window of Day 11- Day 22. On the day of surgery, surgical resection specimen and blood samples will be collected.

• All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events (CTCAE), version 4.03.

• Patients will be followed for 4 weeks after the last dose of the study drug to monitor for any drug-related adverse events. ;

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

• NCT number: NCT02980029
• Study type: Interventional
• Source: University of Kentucky
• Contact: Mark B Evers, MD
• Phone: 859-257-4500
• Email: mark.evers@uky.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: October 6, 2017
• Completion date: December 31, 2024