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

Stemcentrx

Status and phase

Completed

Phase 1

Conditions

Small Cell Lung Carcinoma

Treatments

Drug: Rovalpituzumab Tesirine

Study type

Interventional

Funder types

Industry

Identifiers

SCRX001-007

Details and patient eligibility

About

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

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.