Clinical trial NCT02874664: A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
Official title: An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma
Lead sponsor: Stemcentrx
Sponsor class: INDUSTRY
First posted: 2016-08-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
timeFrame: 12 weeks
measure: Change in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
timeFrame: 12 weeks
measure: Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.
timeFrame: 12 weeks
measure: Incidence of adverse events.
timeFrame: From first dose through 30 days post-last-dose
measure: Objective response rate
timeFrame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
measure: Duration of response
timeFrame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
measure: Progression free survival
timeFrame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
measure: Overall survival
timeFrame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
measure: Clinical benefit ratio
timeFrame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 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.
measure: Area Under the Curve (AUC)
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Greenville
country: United States
facility: Greenville Health System Cancer Institute
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Cancer Centre
state: Ontario
Study officials:
affiliation: AbbVie
name: Daniel Da Costa, PharmD
role: STUDY_DIRECTOR
References: