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

September 20, 2018 updated by: Stemcentrx

An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
12 weeks
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
Time Frame: 12 weeks
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
12 weeks
Incidence of adverse events.
Time Frame: From first dose through 30 days post-last-dose
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stemcentrx

Investigators

  • Study Director: Daniel Da Costa, PharmD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

September 12, 2018

Study Completion (Actual)

September 12, 2018

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRX001-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Carcinoma

Clinical Trials on Rovalpituzumab Tesirine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe