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

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Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Small Cell Lung Carcinoma

Interventions

Rovalpituzumab TesirineDRUG

Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

University of California Los Angeles

Los Angeles, California, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.

Time frame: 12 weeks

Secondary Outcomes

Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.

Time frame: 12 weeks

Change in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.

Time frame: 12 weeks

Change in QRS duration interval from baseline QRS duration following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.

Time frame: 12 weeks

Change in waveform composition interval from baseline waveform composition following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.

Time frame: 12 weeks

Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.

Time frame: 12 weeks

Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.

Time frame: 12 weeks

Incidence of adverse events.

Time frame: From first dose through 30 days post-last-dose

Data from ClinicalTrials.gov

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