This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adult Study: Overall Survival (OS)
Timeframe: From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.
Adult Study: Progression-Free Survival (PFS)
Timeframe: Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years
Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug
Timeframe: From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks
Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414
Timeframe: Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF
Timeframe: Samples collected Cycle 1 Days 1, 2, 3, 5, 8
Pediatric Study: Half-life (t1/2) Observed for ABT-414
Timeframe: Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF
Timeframe: Samples collected Cycle 1 Days 1, 2, 3, 5, 8
Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414
Timeframe: Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose
Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF
Timeframe: Samples collected Cycle 1 Days 1, 2, 3, 5, 8