This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Repeating oral dose
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Oklahoma City, Oklahoma, United States
Unnamed facility
Nashville, Tennessee, United States
Incidence and nature of dose-limiting toxicities (DLTs)
Time frame: Through study completion or early discontinuation
Incidence, nature, and severity of adverse events and serious adverse events, graded according to NCI CTCAE, v4.0
Time frame: Through study completion or early discontinuation
Pharmacokinetic parameters of GDC-0623 (total exposure, maximum and minimum plasma concentrations, time to maximum plasma concentration, elimination half-life)
Time frame: Through study completion or early discontinuation
Objective response for patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Through study completion or early discontinuation
Duration of objective response for patients with measurable disease according to RECIST
Time frame: Through study completion or early discontinuation
Progression-free survival (PFS) for patients with measurable disease according to RECIST
Time frame: Through study completion or early discontinuation
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