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

• Status: Completed
• Trial end date: 2018-09-12
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stemcentrx

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.