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NCT Number: NCT02874664

A Study of Rovalpituzumab Tesirine to Study 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).

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Key information

Conditions

Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rovalpituzumab tesirine

Drug

Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)

Other names: SC16LD6.5

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stemcentrx

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2016
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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