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Study to evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer (SCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rovalpituzumab Tesirine | Drug | Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in QTcF interval from baseline QTcF following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in RR interval from baseline RR following treatment with rovalpituzumab teserine as measured by extracting quantitative ECG parameters from ambulatory Holter monitors. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Da Costa, PharmD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90404 | United States | ||
| Winship Cancer Institute, Emory University |
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| 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. | 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. | 12 weeks |
| Relationship between plasma rovalpituzumab tesirine concentration and change in QTcF interval from baseline. | 12 weeks |
| Incidence of proarrhythmic adverse events stratified by change in QTcF from baseline of less than 10 ms or greater than 10 ms. | 12 weeks |
| Incidence of adverse events. | From first dose through 30 days post-last-dose |
| Objective response rate | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. |
| Duration of response | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. |
| Progression free survival | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. |
| Overall survival | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. |
| Clinical benefit ratio | Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 24 months. |
| Maximum Plasma Concentration (Cmax) | 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) | 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. |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Greenville Health System Cancer Institute | Greenville | South Carolina | 29605 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75230 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| The Ottawa Hospital-Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000620223 | rovalpituzumab tesirine |
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