Outcomes
Primary Outcomes
- Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging
- Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months
- Tumor response assessment via MRI, as long as patient continues to demonstrate response or stable disease and tolerates therapy.
Secondary Outcomes
- Safety evaluation of VAL-083 in combination with a standard radiation therapy, as determined by incidence of patient adverse events and changes in laboratory results, ECG and vital signs (Timeframe: Every 30 days, from patient randomization through 28 days following last study treatment for up to 10 months)
- Ctrough (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Cmax (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Tmax (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- AUClast (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- AUCinf (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- CL/F (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Mean Residence Time (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Vz (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Lambda z (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- T½ (Timeframe: On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose)
- Pharmacokinetic profile and dose-exposure relationship of VAL-083 in Cerebral Spinal Fluid (CSF) (Timeframe: Once after completion of Cycle 1 Day 3 infusion)