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
NCT ID: NCT00927589
Last Updated: 2015-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2009-07-31
2013-02-28
Brief Summary
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The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
carboplatin
Intravenous repeating dose
docetaxel
Intravenous repeating dose
trastuzumab
Intravenous repeating dose
Interventions
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carboplatin
Intravenous repeating dose
docetaxel
Intravenous repeating dose
trastuzumab
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Pretreatment QTcF interval \> 450 ms as determined by local assessment
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Harald Weber, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Scottsdale, Arizona, United States
Beverly Hills, California, United States
La Jolla, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Whittier, California, United States
Miami, Florida, United States
Wichita, Kansas, United States
Billings, Montana, United States
Farmington, New Mexico, United States
The Bronx, New York, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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GO01305
Identifier Type: OTHER
Identifier Source: secondary_id
H4613g
Identifier Type: -
Identifier Source: org_study_id