This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous (IV) infusion of T-DM1 or IV infusion of trastuzumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Changes in cardiac function
Time frame: Through study completion or early study discontinuation
Changes in vital signs, physical findings, and clinical laboratory results during and following administration of study drugs that result in dose modification, dose delay, or discontinuation of T-DM1 and/or GDC 0941
Time frame: Through study completion or early study discontinuation
Incidence, nature, and severity of adverse events
Time frame: Through study completion or early study discontinuation
PK parameters of T-DM1 and GDC-0941 (total exposure, maximum serum concentration, and minimum concentration)
Time frame: Through study completion or early study discontinuation
Progression-free survival (PFS)
Time frame: From study treatment initiation to the first occurrence of disease progression or death on study
Objective response based on investigator assessment
Time frame: Confirmed response >/= 4 weeks after initial documentation of response
Duration of response
Time frame: Time from initial complete or partial response to the time of disease progression or death on study
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