A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
- Registration Number
- NCT02874664
- Lead Sponsor
- Stemcentrx
- Brief Summary
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rovalpituzumab Tesirine Rovalpituzumab Tesirine 0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle
- Primary Outcome Measures
Name Time Method Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. 12 weeks
- Secondary Outcome Measures
Name Time Method Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline. 12 weeks Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms. 12 weeks Progression free survival Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. Area Under the Curve (AUC) Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose. 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. 12 weeks Incidence of adverse events. From first dose through 30 days post-last-dose Clinical benefit ratio Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. 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. 12 weeks Duration of response Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. 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. 12 weeks Objective response rate Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. Maximum Plasma Concentration (Cmax) Cycles 1 and 2: Day 1 (predose, 30 min, 2 and 4 hours postdose) and days 2,3,4,8,15,and 29; Cycles 4,5,7,8: Day 1 predose and 30 min postdose. Overall survival Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Related Research Topics
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Trial Locations
- Locations (15)
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Scroll for more (5 remaining)University of California Los Angeles🇺🇸Los Angeles, California, United States