Status:
COMPLETED
A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) pacl...
Eligibility Criteria
Inclusion
- 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 RECIST
- Agreement to use an effective form of contraception for the duration of the study
Exclusion
- 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, radiotherapy, or hormonal therapy) within 4 weeks or 5 half-lives (whichever is shorter) of the first dose of study treatment
- Uncontrolled current illness
- Active small or large intestine inflammation (such as Crohn's disease or ulcerative colitis)
- Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00960960
Start Date
August 1 2009
End Date
December 1 2015
Last Update
December 15 2016
Active Locations (5)
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1
Peoria, Illinois, United States, 61615
2
Boston, Massachusetts, United States, 02115
3
Nashville, Tennessee, United States, 37232
4
Leuven, Belgium, 3000