NCT03032484

TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma

A Phase 2 Investigator Initiated Study to Determine the Efficacy and Safety of TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.

Detailed description

Eligible patients will be randomized into 2 separate arms: * Arm number one will receive Bevacizumab every 2 weeks in combination with TVB-2640 from day 1 until day 28 of the first cycle. * Arm number two will receive Bevacizumab alone every 2 weeks, from on days 1 and 15 of the first until day 28 of the first cycle. * MR-Spectroscopy will be obtained on all patients (both arms) at day 28 of first cycle. * Starting on cycle 2 day 1, all patients will converge to a single arm and will continue to receive bevacizumab every 2 weeks in combination with TVB-2640. Every cycle will last 28 days.

Conditions

• Astrocytoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
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.

Timeline

• Start date: 2017-05-18
• Primary completion: 2020-04-04
• Completion: 2021-04-05
• First posted: 2017-01-26
• Last updated: 2023-06-15
• Results posted: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study