A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors
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This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.
Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ]
Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ]
Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ]
PK parameters after single and multiple doses of GDC-0068 [ Time Frame: Through study completion or early study discontinuation ]
Secondary Outcome Measures :
Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST [ Time Frame: Through study completion or early study discontinuation ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically documented, incurable, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable.
Evaluable or measurable disease
Life expectancy >= 12 weeks
Adequate hematologic and organ function within 14 days before initiation of GDC-0068
Documented willingness to use an effective means of contraception (e.g., abstinence, hormonal or double barrier method, surgically sterilized partner) for both men and women while participating in the study
History of Type 1 or 2 diabetes mellitus requiring regular medication
Grade > 2 hypercholesterolemia or hypertriglyceridemia
Malabsorption syndrome or other condition that would interfere with enteral absorption
Leptomeningeal disease as the only manifestation of the current malignancy
Known untreated malignancies of the brain or spinal cord, or treated brain metastases that are not radiographically stable for >= 3 months