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Status: RecruitingPhase: Diagnosis: Breast: MetastaticNCT ID: NCT01862081
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-123
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.
Conducting Institutions: Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital
Overall PI: Ian Krop, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Dejan Juric, MD,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100