This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Participants will receive docetaxel 75 milligrams per meter-squared (mg/m\^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
Participants will receive paclitaxel 80 mg/m\^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology, P.A; Baylor Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
...and 4 more locations
Safety: Incidence of adverse events
Time frame: Approximately 3 years
Safety: Incidence of dose limiting toxicities
Time frame: Up to 28 days
Area under the curve from time 0 to the last measurable concentration (AUC0-last)
Time frame: Up to 28 days
Time to maximum observed plasma concentration (Tmax)
Time frame: Up to 28 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 28 days
Minimum observed plasma concentration (Cmin)
Time frame: Up to 28 days
Objective response according to RECIST v1.1
Time frame: Approximately 3 years
Duration of response according to RECIST v1.1
Time frame: Approximately 3 years
Progression-free survival (PFS) according to RECIST v1.1
Time frame: Approximately 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.