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

Sponsor
Stemcentrx (Industry)
Overall Status
Completed
CT.gov ID
NCT02874664
Collaborator
(none)
46
Enrollment
15
Locations
1
Arm
24.3
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
  • Drug: Rovalpituzumab Tesirine
 Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2016
Actual Primary Completion Date :
Sep 12, 2018
Actual Study Completion Date :
Sep 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 Names:
  • 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. [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. [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. [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. [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. [12 weeks]

    5. Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline. [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. [12 weeks]

    7. Incidence of adverse events. [From first dose through 30 days post-last-dose]

    8. Objective response rate [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.]

    9. Duration of response [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.]

    10. Progression free survival [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.]

    11. Overall survival [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.]

    12. Clinical benefit ratio [Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.]

    13. 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.]

    14. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 University of California Los Angeles Los Angeles California United States 90404
    2 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
    3 University of Chicago Medical Center Chicago Illinois United States 60637
    4 Parkview Research Center Fort Wayne Indiana United States 46845
    5 Baptist Health Lexington Lexington Kentucky United States 40503
    6 Karmanos Cancer Institute Detroit Michigan United States 48201
    7 Henry Ford Hospital Detroit Michigan United States 48202
    8 Roswell Park Cancer Institute Buffalo New York United States 14263
    9 University of Cincinnati Cincinnati Ohio United States 45267
    10 University Hospitals Case Medical Center Cleveland Ohio United States 44106
    11 MetroHealth Medical Center Cleveland Ohio United States 44109
    12 Greenville Health System Cancer Institute Greenville South Carolina United States 29605
    13 Mary Crowley Medical Research Center Dallas Texas United States 75230
    14 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    15 The Ottawa Hospital-Cancer Centre Ottawa Ontario Canada K1H 8L6

    Sponsors and Collaborators

    • Stemcentrx

    Investigators

    • Study Director: Daniel Da Costa, PharmD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stemcentrx
    ClinicalTrials.gov Identifier:
    NCT02874664
    Other Study ID Numbers:
    • SCRX001-007
    First Posted:
    Aug 22, 2016
    Last Update Posted:
    Sep 24, 2018
    Last Verified:
    Sep 1, 2018
    Additional relevant MeSH terms:
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Sep 24, 2018