This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Oral escalating dose
Intravenous repeating dose
Karmanos Cancer Institute..
Detroit, Michigan, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo
Villejuif, France
Incidence of all adverse events graded according to NCI CTCAE, v4.0
Time frame: Up to 1 year
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 35 days
Pharmacokinetic property of GDC-0425: determination of plasma drug concentration
Time frame: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: exposure
Time frame: Up to 12 months or early study discontinuation
Pharmacokinetic property of GDC-0425: half-life
Time frame: Up to 12 months or early study discontinuation
Severity of all adverse events graded according to NCI CTCAE, v4.0
Time frame: Up to 1 year
Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease
Time frame: Up to 12 months or early study discontinuation
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