Lung Cancer Clinical Trial
A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
Summary
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
Eligibility Criteria
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.
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There are 15 Locations for this study
Los Angeles California, 90404, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Fort Wayne Indiana, 46845, United States
Lexington Kentucky, 40503, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Buffalo New York, 14263, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44109, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75230, United States
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
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