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A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

Status: Recruiting
Diagnosis: Breast: Metastatic
NCT ID: NCT01862081 (View complete trial on
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

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Age >=18 years - For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease - For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC - For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines - Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment - Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1 - Life expectancy >=12 weeks - Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening - Adequate hematologic and end organ function - Use of highly effective form of contraception Exclusion Criteria: - Prior anti-cancer therapy - Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor - Known significant hypersensitivity to any components of study treatment - Grade >=2 peripheral neuropathy - Type 1 or Type 2 diabetes - Grade >=2 hypercholesterolemia or hypertriglyceridemia - Congenital long QT syndrome - Active congestive heart failure or ventricular arrhythmia
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