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

Phase 1

Completed

• Conditions: Small Cell Lung Carcinoma
• Interventions: Drug: Rovalpituzumab Tesirine

• 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

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Study Start: 2016-09
• Status Verified: 2018-09
• Primary Completion: 2018-09-12
• Study Completion: 2018-09-12
• Last Update Submitted: 2018-09-20
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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.

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

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