This open-label, multicenter, Phase I, dose-escalating study will evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and efficacy of GDC-0084 in patients with progressive or recurrent high-grade glioma. Stage 1 is the dose escalation part of the study. Stage 2, patients will receive GDC-0084 at a recommended dose for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Multiple doses
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Safety: Incidence of adverse events
Time frame: approximately 2 years
Maximum tolerated dose (MTD)
Time frame: approximately 1 year
Pharmacokinetics: Area under the concentration-time curve
Time frame: Pre- and post-dose Days 1, 8, 15, 22 and 29 Cycle 1, Day 1 every following Cycle until 30 days after the last dose of study drug
Best overall response rate, tumor assessments according to Response Assessment in Neuro-Oncology (RANO)
Time frame: approximately 2 years
Duration of response
Time frame: approximately 2 years
Progression-free survival
Time frame: approximately 2 years
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