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

Primary Purpose

Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Rovalpituzumab Tesirine
Sponsored by
Stemcentrx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California Los Angeles
  • Winship Cancer Institute, Emory University
  • University of Chicago Medical Center
  • Parkview Research Center
  • Baptist Health Lexington
  • Karmanos Cancer Institute
  • Henry Ford Hospital
  • Roswell Park Cancer Institute
  • University of Cincinnati
  • University Hospitals Case Medical Center
  • MetroHealth Medical Center
  • Greenville Health System Cancer Institute
  • Mary Crowley Medical Research Center
  • Cross Cancer Institute
  • The Ottawa Hospital-Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rovalpituzumab Tesirine

Arm Description

0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle

Outcomes

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.

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.
Change in PR interval from baseline PR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
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.
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.
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.
Incidence of adverse events.
Objective response rate
Duration of response
Progression free survival
Overall survival
Clinical benefit ratio
Maximum Plasma Concentration (Cmax)
Area Under the Curve (AUC)

Full Information

First Posted
August 16, 2016
Last Updated
September 20, 2018
Sponsor
Stemcentrx
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1. Study Identification

Unique Protocol Identification Number
NCT02874664
Brief Title
A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stemcentrx

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rovalpituzumab Tesirine
Arm Type
Experimental
Arm Description
0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab Tesirine
Other Intervention Name(s)
SC16LD6.5
Intervention Description
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
Time Frame
12 weeks
Title
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
Title
Incidence of adverse events.
Time Frame
From first dose through 30 days post-last-dose
Title
Objective response rate
Time Frame
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Title
Duration of response
Time Frame
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Title
Progression free survival
Time Frame
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Title
Overall survival
Time Frame
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Title
Clinical benefit ratio
Time Frame
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Da Costa, PharmD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Greenville Health System Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
The Ottawa Hospital-Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

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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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