This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetic (PK) of GDC-0349 administered once daily (QD), orally (PO).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Oral escalating dose
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Toronto, Ontario, Canada
Incidence of dose limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Time frame: Up to 30 days
Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0349
Time frame: Up to 2 years
Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0349
Time frame: Up to 30 days
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