Solid Cancers
Conditions
Brief summary
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.
Interventions
DRUGGDC-0068
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters after single and multiple doses of GDC-0068 | Through study completion or early study discontinuation |
| Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068 | Through study completion or early study discontinuation |
| Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068 | 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 | Through study completion or early study discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST | Through study completion or early study discontinuation |
Countries
Spain
Outcome results
None listed