Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02980029
Status:
TERMINATED
Last Update Posted:
2024-01-19
First Post:
2016-10-12
Brief Title:
TVB 2640 for Resectable Colon Cancer Other Resectable Cancers a Window Trial
Sponsor:
Mark Evers
Organization:
University of Kentucky
Study Overview
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:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated by the PRMC for low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 21 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 ie 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 403
Patients will be followed for 4 weeks after the last dose of the study drug to monitor for any drug-related adverse events
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 21 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 ie 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 403
Patients will be followed for 4 weeks after the last dose of the study drug to monitor for any drug-related adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MCC-16-GI-98 | OTHER | None | None |
| R01CA208343 | NIH | UK Markey Cancer Center former protocol number | httpsreporternihgovquickSearchR01CA208343 |