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

NCT ID: NCT02874664

Last Updated: 2018-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Small Cell Lung Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Rovalpituzumab Tesirine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rovalpituzumab Tesirine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SC16LD6.5

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stemcentrx

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel Da Costa, PharmD

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California Los Angeles

Los Angeles, California, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Greenville Health System Cancer Institute

Greenville, South Carolina, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

The Ottawa Hospital-Cancer Centre

Ottawa, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCRX001-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.