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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT03032484
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
  • TVB-2640 — DRUG
    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.

Study Details

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

Key Dates

First listed
Jan 26, 2017
Start date
May 18, 2017
Status verified
Jun 2023
Primary completion
Apr 4, 2020
Completion
Apr 5, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and TVB-2640
    Bevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
  • Experimental: Bevacizumab for Cycle 1, then Bevacizumab and TVB-2640
    Bevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle, and then receive both Bevacizumab and TVB-2640 for the remainder of their participation in this study.

Primary Outcome Measure

Progression Free Survival at 6 Months (PFS6) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research CenterSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
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By specialty
OncologyNeuro-oncology
By research site
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center· San Antonio, TX

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