A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
1 other identifier
interventional
46
2 countries
15
Brief Summary
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2016
Typical duration for phase_1
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2018
CompletedSeptember 24, 2018
September 1, 2018
2 years
August 16, 2016
September 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
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
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
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
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
12 weeks
- +9 more secondary outcomes
Study Arms (1)
Rovalpituzumab Tesirine
EXPERIMENTAL0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle
Interventions
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stemcentrxlead
Study Sites (15)
University of California Los Angeles
Los Angeles, California, 90404, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, 29605, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75230, United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
The Ottawa Hospital-Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Da Costa, PharmD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 22, 2016
Study Start
September 1, 2016
Primary Completion
September 12, 2018
Study Completion
September 12, 2018
Last Updated
September 24, 2018
Record last verified: 2018-09