Small Cell Lung CarcinomaPhase 1NCT02874664
A Study of Rovalpituzumab Tesirine to Study Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
A Phase 1 study testing Rovalpituzumab Tesirine in people with Small Cell Lung Carcinoma, run by Stemcentrx at 15 sites in 2 countries.
Trial summary
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- Rovalpituzumab Tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Sep 2016to 12 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Mary Crowley Medical Research Center
Dallas, Texas, 75230
Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Parkview Research Center
Fort Wayne, Indiana, 46845
Greenville Health System Cancer Institute
Greenville, South Carolina, 29605
Baptist Health Lexington
Lexington, Kentucky, 40503
University of California Los Angeles
Los Angeles, California, 90404
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
The Ottawa Hospital-Cancer Centre
Ottawa, Ontario, K1H 8L6
About this study
Official title: 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).
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- Rovalpituzumab Tesirine
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rovalpituzumab TesirineDrug
Also called SC16LD6.5
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
| Study group | Role | What they receive |
|---|---|---|
| Rovalpituzumab Tesirine | Experimental | 0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle Receives: Drug: Rovalpituzumab Tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
Measured: 12 weeks
Secondary outcomes (14)
Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
Measured: 12 weeks
Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms.
Measured: 12 weeks
Incidence of adverse events.
Measured: From first dose through 30 days post-last-dose
Objective response rate
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Duration of response
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Progression free survival
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Overall survival
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Clinical benefit ratio
Measured: Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months.
Maximum Plasma Concentration (Cmax)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemcentrx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Da Costa, PharmD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874664
- Sponsor's protocol ID
- SCRX001-007
- Status last verified
- Sep 2018
- First submitted
- 16 Aug 2016
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization in Subjects With Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02874664
- Acronym / sponsor ID
- SCRX001-007
- Conditions
- Small Cell Lung Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- StemcentrxIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rovalpituzumab Tesirine | Experimental | Drug: Rovalpituzumab Tesirine0.3 mg/kg rovalpituzumab tesirine intravenously on Day 1 of every 6-week treatment cycle for 2 cycles omitting every third cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rovalpituzumab TesirineAlso: SC16LD6.5Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC) | Drug | Rovalpituzumab Tesirine |
Primary outcome
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
14 secondary outcomes
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
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
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
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
Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline.
Time frame: 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
Incidence of adverse events.
Time frame: 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.
Duration of response
Time frame: 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.
Overall survival
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Da Costa, PharmD study director
AbbVie
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rovalpituzumab Tesirine in people with Small Cell Lung Carcinoma, run by Stemcentrx at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.