Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
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.
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
San Antonio, Texas, United States
Progression Free Survival at 6 Months (PFS6)
Survival of participants at 6 months after the start of treatment without their condition becoming any worse. Brain magnetic resonance imaging (MRI) was performed after every even cycle (e.g., C2, C4) during treatment, with tumor response assessed by the investigator for complete response (CR), partial response (PR) and PD according to the Response Assessment in Neuro-oncology (RANO) criteria.
Time frame: 6 months
Incidence, Nature and Severity of Adverse Events and Serious Adverse Events, Graded According to NCI - Common Toxicity Criteria for Adverse Events Version (4.03)
Number of adverse of any nature are reported as well as the number of adverse events that were classed as grade 3-5 on the NCI - Common Toxicity Criteria for Adverse Events
Time frame: Up to 6 28-day cycles
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