Status:
COMPLETED
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokineti...
Eligibility Criteria
Inclusion
- Histologic documentation of a HER2-positive solid malignancy in patients with metastatic or locally advanced inoperable disease
- Left ventricular ejection fraction (LVEF) \>/= 50% by multiple-gated acquisition (MUGA) scan or two-dimensional echocardiography (ECHO) \</= 42 days prior to Cycle 1, Day 1
Exclusion
- History of trastuzumab treatment \</= 100 days prior to Cycle 1, Day 1
- Pretreatment QTcF interval \> 450 ms as determined by local assessment
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00927589
Start Date
July 1 2009
End Date
February 1 2013
Last Update
December 10 2015
Active Locations (20)
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1
Scottsdale, Arizona, United States, 85258
2
Beverly Hills, California, United States, 90211
3
La Jolla, California, United States, 92093
4
San Diego, California, United States, 92123