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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874664
• Other study ID #: SCRX001-007
• Status: Completed
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: September 12, 2018

Study information

• Verified date: September 2018
• Source: Stemcentrx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	The Ottawa Hospital-Cancer Centre	Ottawa	Ontario
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Greenville Health System Cancer Institute	Greenville	South Carolina
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Stemcentrx

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.		12 weeks
Secondary	Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.		12 weeks
Secondary	Incidence of adverse events.		From first dose through 30 days post-last-dose
Secondary	Objective response rate		Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Secondary	Duration of response		Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Secondary	Progression free survival		Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Secondary	Overall survival		Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Secondary	Clinical benefit ratio		Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Secondary	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.
Secondary	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.