This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0980 administered to patients with incurable, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Escalating repeating dose
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Villejuif, France
Unnamed facility
Manchester, United Kingdom
Occurrence of adverse events
Time frame: Length of study
Occurrence of dose-limiting toxicities
Time frame: Length of study
Occurrence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0980
Time frame: Length of study
PK parameters after doses of GDC-0980
Time frame: Length of study
Best overall response, duration of objective response, and progression-free survival for patients with measurable disease according to RECIST
Time frame: Length of study
PET response for patients with detectable FDG tumor uptake at baseline
Time frame: Length of study
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