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

Completed · Phase 1

Conditions studied: Small Cell Lung Carcinoma

In brief

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

Key facts

Study ID

NCT02874664

Run by

Stemcentrx

People needed

46

Starts

2016-09-01

Expected to finish

2018-09-12

Last updated by the study team

2018-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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