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

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ClinicalTrials.gov Identifier: NCT02874664
Recruitment Status : Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Stemcentrx

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

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



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. ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874664


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

Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02874664     History of Changes
Other Study ID Numbers: SCRX001-007
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: February 2018

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