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).

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

46

Study ID:

NCT02874664

Recruitment Status:

Completed

Sponsor:

Stemcentrx

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There are 15 Locations for this study

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University of California Los Angeles
Los Angeles California, 90404, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Parkview Research Center
Fort Wayne Indiana, 46845, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Greenville Health System Cancer Institute
Greenville South Carolina, 29605, United States
Mary Crowley Medical Research Center
Dallas Texas, 75230, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
The Ottawa Hospital-Cancer Centre
Ottawa Ontario, K1H 8, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

46

Study ID:

NCT02874664

Recruitment Status:

Completed

Sponsor:


Stemcentrx

How clear is this clinincal trial information?

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