This, international, multi-center, Phase 2 study of verubulin will be conducted in patients with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts. Part A is an open-label dose finding study that will determine the safety and tolerability of verubulin in combination with standard treatment. Part B is a randomized open-label study that will investigate progression-free survival and overall survival of patients receiving verubulin, at the dose determined in Part A, in combination with standard treatment versus standard treatment alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide \& Radiation Therapy
Temozolomide \& Radiation Therapy
Stanford University
Stanford, California, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Part A: Safety
Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability.
Time frame: 14 weeks
Part B: 9 Mo Progression-free survival
Time frame: 9 Month
Part A: Pharmacokinetic Parameters
Measure the amount of verubulin in the body at specific time points when given with standard of care Radiation Therapy and Temozolomide
Time frame: 18 weeks
Part B: 6 Mo Progression Free Survival
Assess 6-month progression-free survival and compare median progression-free survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Time frame: 6 month
Overall Survival
Assess overall survival and compare median overall survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Time frame: 18 months
Part B: 12 Mo Progression Free Survival
Assess 12-month progression-free survival and compare median progression-free survival time for Radiation Therapy plus Temozolomide (TMZ)plus verubulin to standard of care (Radiation Therapy plus TMZ alone)
Time frame: 12 months
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