For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Histologically or cytologically confirmed extensive-stage small-cell lung cancer (SCLC).
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  3. Adequate hematologic and organ function as confirmed by laboratory values

EXCLUSION CRITERIA

  1. 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
  2. Recent or ongoing serious infection
  3. Women who are pregnant or breastfeeding
  4. 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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Small Cell Lung Carcinoma

Age

18+

Phase

Phase 1

Participants needed

46

Est. Completion Date

Oct 2018

Treatment type

Interventional


Sponsor

Stemcentrx

ClinicalTrials.gov identifier

NCT02874664

Study number

SCRX001-007

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