Status:
COMPLETED
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
Lead Sponsor:
Genentech, Inc.
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combinatio...
Eligibility Criteria
Inclusion
- Histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting
- HER2-positive disease documented by one of the following results using FDA-approved testing methods: FISH-positive, chromogenic in situ hybridization (CISH)-positive, or IHC 3 + by local laboratory assessment
- Life expectancy \>= 90 days
- Agreement to use an effective form of contraception for the duration of the study
Exclusion
- History of Grade \>= 3 hypersensitivity reaction to trastuzumab, or Grade \>= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions
- History of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued
- Prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to Day 1
- Prior investigational anti-cancer therapy within 4 weeks prior to Day 1
- Grade \>= 2 peripheral neuropathy
- History of Grade \>= 3 hyperglycemia (fasting)
- History of Type 1 or Type 2 diabetes requiring daily medication
- History of clinically significant cardiac or pulmonary dysfunction
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- 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
- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents
- Any condition requiring \> 2 grams of acetaminophen daily
- Need for current chronic corticosteroid therapy
- Pregnancy, lactation, or breast-feeding
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Major surgical procedure or significant traumatic injury within 28 days prior to Day 1, or anticipation of the need for major surgery during the course of study treatment
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00928330
Start Date
July 1 2009
End Date
January 1 2014
Last Update
November 2 2016
Active Locations (3)
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1
Indianapolis, Indiana, United States, 46202
2
Baltimore, Maryland, United States, 21231
3
Boston, Massachusetts, United States, 02115