A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer

Status: Recruiting
Phase:
Diagnosis: Breast: Metastatic
NCT ID: NCT00960960 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 09-161

 

This is an open-label, multicenter, phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with intravenous (IV) paclitaxel and IV bevacizumab in patients with locally recurrent or metastatic breast cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Eric Winer, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease - Adequate organ and bone marrow function as assessed by laboratory tests - Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST) - Agreement to use an effective form of contraception for the duration of the study Exclusion Criteria: - History of Grade ≥ 3 fasting hyperglycemia - History of diabetes requiring regular medication - History of malabsorption syndrome or other condition that would interfere with enteral absorption - Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents - Prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment - Uncontrolled current illness - Active autoimmune disease requiring the equivalent of >10 mg/day of prednisone - Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus - Known HIV infection - New York Heart Association (NYHA) Class II or greater congestive heart failure - Active ventricular arrhythmia requiring medication - Pregnancy, lactation, or breastfeeding - Known significant hypersensitivity to study drugs or excipients - History of arterial thromboembolic disease within 6 months of first study treatment - No more than two prior chemotherapy regimens for metastatic disease - No prior taxane therapy for metastatic disease
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