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An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
Primary:
To evaluate the effect of treatment with rovalpituzumab tesirine on cardiac ventricular repolarization (QT/QTc) in subjects with small cell lung cancer (SCLC)
Secondary:
To evaluate the effect of treatment with rovalpituzumab tesirine on other electrocardiogram (ECG) parameters, including the RR interval, PR interval, QRS duration, and waveform composition
To investigate the relationship between QT interval corrected for heart rate (QTc) interval change and rovalpituzumab tesirine concentrations
To investigate the relationship between QTc interval change and proarrhythmic adverse events (AEs)
To determine the anti-tumor activity of rovalpituzumab tesirine in subjects with SCLC
To assess the safety of treatment with rovalpituzumab tesirine
To determine the pharmacokinetics (PK) of rovalpituzumab tesirine
Exploratory:
To determine the incidence of anti-therapeutic antibodies (ATA) against rovalpituzumab tesirine
To evaluate the tumor expression of delta-like protein 3 (DLL3)
Primary:
To evaluate the effect of treatment with rovalpituzumab tesirine on cardiac ventricular repolarization (QT/QTc) in subjects with small cell lung cancer (SCLC)
Secondary:
To evaluate the effect of treatment with rovalpituzumab tesirine on other electrocardiogram (ECG) parameters, including the RR interval, PR interval, QRS duration, and waveform composition
To investigate the relationship between QT interval corrected for heart rate (QTc) interval change and rovalpituzumab tesirine concentrations
To investigate the relationship between QTc interval change and proarrhythmic adverse events (AEs)
To determine the anti-tumor activity of rovalpituzumab tesirine in subjects with SCLC
To assess the safety of treatment with rovalpituzumab tesirine
To determine the pharmacokinetics (PK) of rovalpituzumab tesirine
Exploratory:
To determine the incidence of anti-therapeutic antibodies (ATA) against rovalpituzumab tesirine
To evaluate the tumor expression of delta-like protein 3 (DLL3)
Recruitment Status
Past Studies