A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:September 2016
End Date:September 12, 2018

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An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer

Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization
in subjects with small cell lung cancer (SCLC).


Inclusion Criteria:

- Histologically or cytologically confirmed extensive-stage small-cell lung cancer
(SCLC).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

- Adequate hematologic and organ function as confirmed by laboratory values

Exclusion Criteria:

- Clinically significant cardiac abnormalities including QRS duration of >120 msec; QTcF
>470 msec for women and >450 msec for men; Abnormal cardiac rhythm; Clinically
significant cardiac valve abnormality; Documented history of left ventricular ejection
fraction <0.30 within 6 months; Permanent pacemaker or automatic implantable
cardioverter defibrillator; History of torsades de pointes, congenital long QT
syndrome, or family history of long QT syndrome or sudden death

- 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.
We found this trial at
14
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Fort Wayne, Indiana 46805
Principal Investigator: Alexander Starodub, MD
Phone: 260-266-5600
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Grace Dy, MD
Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Jonathan Goldman, MD
Phone: 310-633-8400
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Taofeek Owonikoko, MD
Phone: 404-778-1868
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jyoti Patel, MD
Phone: 855-702-8222
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Nagla A Karim, MD
Phone: 513-245-3417
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, Ohio 44194
Principal Investigator: Afshin Dowlati, MD
Phone: 216-844-7704
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Debora Bruno, MD
Phone: 216-778-7328
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Dallas, Texas 75201
Principal Investigator: John Nemunaitis, MD
Phone: 972-566-3000
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Detroit, Michigan 48201
Principal Investigator: Shirish Gadgeel, MD
Phone: 800-527-6266
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Igor Rybkin, MD
Phone: 800-436-7936
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Edmonton, Alberta
Principal Investigator: Quincy Chu, MD
Phone: 780-432-8771
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey Edenfield, MD
Phone: 864-455-7070
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Lexington, Kentucky 40503
Principal Investigator: Firas Badin, MD
Phone: 856-359-2496
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