This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Oral repeating dose
Oral repeating dose
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
New Brunswick, New Jersey, United States
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Utrecht, Netherlands
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
Tumor response
Time frame: Assessed at periodic intervals
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)
Time frame: Through study completion or early study discontinuation
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