Glioblastoma Multiforme
Conditions
Keywords
Glioblastoma, Brain Neoplasms, Brain Cancer, Verubulin
Brief summary
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.
Interventions
DRUGVerubulin
Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy
DRUGTemozolomide & Radiation Therapy
Temozolomide & Radiation Therapy
Sponsors
Myrexis Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. Have histologically proven, newly diagnosed glioblastoma multiforme 2. Age ≥ 18 years and \< 70 years 3. Have an ECOG performance score of 0, 1, or 2, or KPS ≥ 70 4. Have adequate bone marrow function , liver function, and kidney function before starting therapy 5. Begin study therapy no more than 6 weeks after surgery or biopsy 6. Subjects that have had surgery must have an MRI ≤ 72 hours after surgery
Exclusion criteria
1. Have a carmustine implant (e.g., Gliadel® Wafer) 2. Have uncontrolled hypertension (SBP \> 140 mmHg or DBP \> 90 mmHg for more than 1 week) 3. Have a left ventricular ejection fraction below the lower limit of the reference range for the institution, as measured by multiple gated acquisition (MUGA) or echocardiogram (ECHO) 4. Have Troponin-I or Troponin T at Screening visit elevated above the upper limit of the reference range of the local institution 5. Have an increasing steroid requirement, indicative of a rapidly progressive disease 6. Have evidence of new, active intra tumor hemorrhage ≥ CTCAE Grade 2 7. Have had prior cranial radiotherapy 8. Have history of stroke and/or transient ischemic attack within 2 years of screening 9. Have history of cardiovascular disease (e.g., angina, myocardial infarction, congestive heart failure, etc.) within 2 years of screening 10. Be pregnant or breast feeding 11. Have a history of hypersensitivity reaction to Cremophor® EL 12. Have a history of hypersensitivity reaction or intolerance to temozolomide or dacarbazine (DTIC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Safety | 14 weeks | Assess the number and percentage of subjects with adverse events, abnormal laboratory parameters, and ECG changes as measures of safety and tolerability. |
| Part B: 9 Mo Progression-free survival | 9 Month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Pharmacokinetic Parameters | 18 weeks | Measure the amount of verubulin in the body at specific time points when given with standard of care Radiation Therapy and Temozolomide |
| Part B: 6 Mo Progression Free Survival | 6 month | 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) |
| Overall Survival | 18 months | 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) |
| Part B: 12 Mo Progression Free Survival | 12 months | 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) |
Countries
United States
Outcome results
None listed