A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
NCT ID: NCT02874664
Last Updated: 2018-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2016-09-30
2018-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rovalpituzumab Tesirine
0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle
Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
Interventions
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Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* Adequate hematologic and organ function as confirmed by laboratory values
Exclusion Criteria
* Recent or ongoing serious infection
* Women who are pregnant or breastfeeding
* Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation.
18 Years
ALL
No
Sponsors
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Stemcentrx
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Da Costa, PharmD
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of California Los Angeles
Los Angeles, California, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
The Ottawa Hospital-Cancer Centre
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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SCRX001-007
Identifier Type: -
Identifier Source: org_study_id
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