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CompletedPhase 1NCT02874664
Official study title

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

Study summary

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 things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRovalpituzumab Tesirine

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 24, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Stemcentrx

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Stemcentrx
Interventions being studied
Drug: Rovalpituzumab Tesirine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California Los AngelesLos Angeles, California
  • Winship Cancer Institute, Emory UniversityAtlanta, Georgia
  • University of Chicago Medical CenterChicago, Illinois
  • Parkview Research CenterFort Wayne, Indiana
  • Baptist Health LexingtonLexington, Kentucky
  • Karmanos Cancer InstituteDetroit, Michigan
  • Henry Ford HospitalDetroit, Michigan
  • Roswell Park Cancer InstituteBuffalo, New York
  • University of CincinnatiCincinnati, Ohio
  • University Hospitals Case Medical CenterCleveland, Ohio
  • MetroHealth Medical CenterCleveland, Ohio
  • Greenville Health System Cancer InstituteGreenville, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 24, 2018. Always confirm current availability with the study team.

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