Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-17-087
Prinicipal Investigator
Aregawi, Dawit
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
BGB-290-104
Title
A Phase 1b/2 study to assess the safety, tolerability and efficacy of BGB-290 in combination with radiation therapy and/or temozolomide in subjects with first-line or recurrent/refractory glioblastoma
Objective
Primary
Phase 1b
Arm A (BGB-290 + radiation therapy [RT]): Subjects with first-line glioblastoma (GB) with unmethylatedMGMT promoter (?unmethylated GB?)
To assess safety and tolerability of BGB-290 combined with RT
To identify dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or
maximum administered dose (MAD) for BGB-290 combined with RT
To select the recommended Phase 2 schedule for full-dose BGB 290 combined with RT

Arm B (BGB-290 + RT + temozolomide [TMZ]): Subjects with first-line unmethylated GB
To assess safety and tolerability of BGB-290 combined with RT and TMZ
To identify DLTs and determine the MTD or MAD for TMZ combined with RT and the MTD/MAD
for BGB-290 of Arm A
To select the RP2D for TMZ combined with RT and the MTD/MAD for BGB-290 of Arm A

Arm C (BGB-290 + TMZ): Subjects with recurrent/refractory GB
To assess safety and tolerability of BGB-290 combined with TMZ
To identify DLTs and determine the MTD or MAD for TMZ combined with full-dose BGB-290
To select the RP2D for TMZ combined with full-dose BGB 290
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center