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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Stemcentrx
Sponsor:
Information provided by (Responsible Party):
Stemcentrx
ClinicalTrials.gov Identifier:
NCT02874664
First received: August 16, 2016
Last updated: June 16, 2017
Last verified: January 2017
  Purpose
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).

Condition Intervention Phase
Small Cell Lung Carcinoma Drug: Rovalpituzumab Tesirine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Stemcentrx:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline. [ Time Frame: 12 weeks ]
  • 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 ]
  • Incidence of adverse events. [ Time Frame: From first dose through 30 days post-last-dose ]
  • Objective response rate [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
  • Duration of response [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
  • Progression free survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
  • Overall survival [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
  • Clinical benefit ratio [ Time Frame: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. ]
  • 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. ]
  • 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. ]

Estimated Enrollment: 50
Study Start Date: September 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02874664

Contacts
Contact: SCRX001-007 Study Team SCRX001-007@stemcentrx.com

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90404
Contact    310-633-8400      
Principal Investigator: Jonathan Goldman, MD         
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-1868      
Principal Investigator: Taofeek Owonikoko, MD         
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact    855-702-8222      
Principal Investigator: Jyoti Patel, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact    800-527-6266      
Principal Investigator: Shirish Gadgeel, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact    877-275-7724      
Principal Investigator: Grace Dy, MD         
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Joy Volpi    216-844-7704      
Principal Investigator: Afshin Dowlati, MD         
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605
Contact    864-455-7070      
Principal Investigator: Jeffrey Edenfield, MD         
United States, Texas
Mary Crowley Medical Research Center Recruiting
Dallas, Texas, United States, 75230
Contact    972-566-3000      
Principal Investigator: John Nemunaitis, MD         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact    780-432-8771      
Principal Investigator: Quincy Chu, MD         
Sponsors and Collaborators
Stemcentrx
Investigators
Study Director: Edward Kavalerchik, MD Stemcentrx
  More Information

Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02874664     History of Changes
Other Study ID Numbers: SCRX001-007
Study First Received: August 16, 2016
Last Updated: June 16, 2017

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 23, 2017