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

• ClinicalTrials.gov Identifier: NCT02874664
• Recruitment Status: Completed
• First Posted: August 22, 2016
• Last Update Posted: September 24, 2018
• Sponsor: Stemcentrx
• Information provided by (Responsible Party): Stemcentrx

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Small Cell Lung Carcinoma	Drug: Rovalpituzumab Tesirine	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: September 2016
• Actual Primary Completion Date: September 12, 2018
• Actual Study Completion Date: September 12, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Rovalpituzumab Tesirine; Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC); Other Name: SC16LD6.5

Outcome Measures

Primary Outcome Measures :

1. Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. [ Time Frame: 12 weeks ]
2. Change in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. [ Time Frame: 12 weeks ]
3. 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. [ Time Frame: 12 weeks ]
4. 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. [ Time Frame: 12 weeks ]
5. Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline. [ Time Frame: 12 weeks ]
6. Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms. [ Time Frame: 12 weeks ]
7. Incidence of adverse events. [ Time Frame: From first dose through 30 days post-last-dose ]
8. Objective response rate [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
9. Duration of response [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
10. Progression free survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
11. Overall survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
12. Clinical benefit ratio [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
13. Maximum Plasma Concentration (Cmax) [ Time Frame: 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. ]
14. Area Under the Curve (AUC) [ Time Frame: 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California Los Angeles

Los Angeles, California, United States, 90404

United States, Georgia

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States, 30322

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

United States, Indiana

Parkview Research Center

Fort Wayne, Indiana, United States, 46845

United States, Kentucky

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Henry Ford Hospital

Detroit, Michigan, United States, 48202

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45267

University Hospitals Case Medical Center

Cleveland, Ohio, United States, 44106

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

United States, South Carolina

Greenville Health System Cancer Institute

Greenville, South Carolina, United States, 29605

United States, Texas

Mary Crowley Medical Research Center

Dallas, Texas, United States, 75230

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Canada, Ontario

The Ottawa Hospital-Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Stemcentrx

Investigators

• Study Director: Daniel Da Costa, PharmD; AbbVie

More Information

• Responsible Party: Stemcentrx
• ClinicalTrials.gov Identifier: NCT02874664
• Other Study ID Numbers: SCRX001-007
• First Posted: August 22, 2016
• Last Update Posted: September 24, 2018
• Last Verified: September 2018

Additional relevant MeSH terms:

Small Cell Lung Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases