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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003726-17 | EudraCT Number |
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The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rovalpituzumab tesirine | Experimental | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
|
| Topotecan | Active Comparator | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rovalpituzumab tesirine | Drug | Powder for solution for infusion in vials. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method. | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute /ID# 155873 | Huntsville | Alabama | 35805 | United States | ||
| Mitchell Cancer Institute /ID# 158151 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31506387 | Background | Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10. | |
| 29290251 |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topotecan | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle. |
| FG001 | Rovalpituzumab Tesirine | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2019 | Jan 29, 2021 |
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| Topotecan | Drug | Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region. |
|
| Dexamethasone | Drug | Oral tablet. |
|
| From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent). | Baseline, Week 7 |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| Clinical Benefit Rate (CBR) | CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| Duration of Objective Response (DOR) | DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Carti /Id# 156982 | Little Rock | Arkansas | 72205 | United States |
| Highlands Oncology Group /ID# 155902 | Springdale | Arkansas | 72762 | United States |
| Cedars-Sinai Medical Center /ID# 157102 | Beverly Hills | California | 90211 | United States |
| Moore UC San Diego Cancer Center /ID# 156965 | La Jolla | California | 92093 | United States |
| Los Angeles Hematology Oncolog /ID# 155879 | Los Angeles | California | 90017 | United States |
| University of California, Davis Comprehensive Cancer Center /ID# 157001 | Sacramento | California | 95817 | United States |
| St Jude Hospital dba St Joseph /ID# 155899 | Santa Rosa | California | 95403 | United States |
| Icri /Id# 157090 | Whittier | California | 90603 | United States |
| Christiana Care Health Service /ID# 158171 | Newark | Delaware | 19713 | United States |
| Cancer Specialists of North Florida - Southpoint /ID# 155828 | Jacksonville | Florida | 32256 | United States |
| Georgia Cancer Center /ID# 160206 | Atlanta | Georgia | 30342 | United States |
| St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550 | Meridian | Idaho | 83712 | United States |
| NorthShore University HealthSystem - Evanston Hospital /ID# 157054 | Evanston | Illinois | 60201 | United States |
| Ingalls Memorial Hosp /ID# 155871 | Harvey | Illinois | 60426 | United States |
| Goshen Center for Cancer Care /ID# 155946 | Goshen | Indiana | 46526 | United States |
| University of Louisville /ID# 155947 | Louisville | Kentucky | 40202 | United States |
| Ochsner Clinic Foundation /ID# 160807 | Baton Rouge | Louisiana | 70836-6455 | United States |
| Dana-Farber Cancer Institute /ID# 160210 | Boston | Massachusetts | 02215 | United States |
| Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021 | Lansing | Michigan | 48912 | United States |
| Nebraska Hematology Oncology /ID# 155900 | Lincoln | Nebraska | 68506 | United States |
| Gabrail Cancer Center Research /ID# 155920 | Canton | Ohio | 44718 | United States |
| Oregon Health and Science University /ID# 157055 | Portland | Oregon | 97239 | United States |
| UPMC Hillman Cancer Ctr /ID# 164403 | Pittsburgh | Pennsylvania | 15232 | United States |
| Univ Medical Ctr Brackenridge /ID# 156967 | Austin | Texas | 78701 | United States |
| UT Southwestern Medical Center /ID# 158150 | Dallas | Texas | 75390-7208 | United States |
| University of Vermont Medical Center /ID# 162317 | Burlington | Vermont | 05401-1473 | United States |
| University of Washington /ID# 162626 | Seattle | Washington | 98109 | United States |
| Medical Oncology Associates /ID# 156856 | Spokane | Washington | 99208 | United States |
| West Virginia Univ School Med /ID# 155872 | Morgantown | West Virginia | 26506 | United States |
| Blacktown Hospital /ID# 158907 | Blacktown | New South Wales | 2148 | Australia |
| St George Hospital /ID# 158855 | Kogarah | New South Wales | 2217 | Australia |
| Southern Medical Day Care Ctr /ID# 158853 | Wollongong | New South Wales | 2500 | Australia |
| The Prince Charles Hospital /ID# 158897 | Chermside | Queensland | 4032 | Australia |
| Ballarat Health Service /ID# 158904 | Ballarat | Victoria | 3350 | Australia |
| Austin Hospital /ID# 158898 | Heidelberg | Victoria | 3084 | Australia |
| Bobruysk Interdistrict Onco. /ID# 169394 | Babruysk | 213825 | Belarus |
| State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325 | Lesnoy | 223040 | Belarus |
| Mogilev Reg. Oncologic dispe /ID# 159326 | Mogilev | 212018 | Belarus |
| CHU Saint-Pierre /ID# 159521 | Brussels | Brussels Capital | 1000 | Belgium |
| Grand Hôpital de Charleroi /ID# 158748 | Charleroi | Hainaut | 6000 | Belgium |
| Cliniques universitaires Saint /ID# 158751 | Brussels | 1200 | Belgium |
| Hopital de Jolimont /ID# 159755 | Haine-Saint-Paul | 7100 | Belgium |
| UZ Leuven /ID# 158752 | Leuven | 3000 | Belgium |
| CHU de Liege Sart Tilman /ID# 158753 | Liège | 4000 | Belgium |
| CHU Charleroi (Vesale) /ID# 159756 | Montigny-le-Tilleul | 6110 | Belgium |
| Liga Norte Rio Grandense Cont. /ID# 159015 | Natal | Rio Grande do Norte | 59075-740 | Brazil |
| Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668 | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017 | Barretos | São Paulo | 14784-400 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666 | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665 | Rio de Janeiro | 20231-050 | Brazil |
| UMHAT Tsaritsa Joanna - ISUL /ID# 159641 | Sofia | 1527 | Bulgaria |
| UMHAT Sv. Ivan Rilski /ID# 159642 | Sofia | 1612 | Bulgaria |
| Cross Cancer Institute /ID# 159519 | Edmonton | Alberta | T6G 1Z2 | Canada |
| Juravinski Cancer Clinic /ID# 159514 | Hamilton | Ontario | L8V 1C3 | Canada |
| Hopital du Sacre Coeur Montreal /ID# 159515 | Montreal | Quebec | H4J 1C5 | Canada |
| CHU de Quebec-Universite Laval /ID# 159093 | Québec | Quebec | G1R 2J6 | Canada |
| Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931 | Rimouski | Quebec | G5L 5T1 | Canada |
| Jilin Cancer Hosptial /ID# 204059 | Changchun | Jilin | 130000 | China |
| Klinicki bolnicki centar Sestre milosrdnice /ID# 158811 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinika za plucne bolesti Jordanovac /ID# 159502 | Zagreb | City of Zagreb | 10000 | Croatia |
| Klinicki bolnicki centar Rijeka /ID# 159501 | Rijeka | Primorje-Gorski Kotar County | 51000 | Croatia |
| Thomayerova nemocnice /ID# 159061 | Prague | Praha 4 | 140 59 | Czechia |
| Nemocnice Na Plesi s.r.o. /ID# 161190 | Nová Ves pod Pleší | Pribram | 262 04 | Czechia |
| Nemocnice Rudolfa a Stefanie /ID# 159652 | Benešov | 256 01 | Czechia |
| Nemocnice Horovice a.s. /ID# 161191 | Hořovice | 268 31 | Czechia |
| Krajska nemocnice Liberec a.s. /ID# 159653 | Liberec | 602 00 | Czechia |
| Herlev Hospital /ID# 158049 | Herlev | Capital Region | 2730 | Denmark |
| Odense Universitets Hospital /ID# 158050 | Odense C | Region Syddanmark | 5000 | Denmark |
| Rigshospitalet, Finsen Centre /ID# 158051 | Copenhagen | 2100 | Denmark |
| Hopital Haut-Lévêque /ID# 160558 | Pessac | Gironde | 33604 | France |
| Assis.Publique-Hopital Nord /ID# 160554 | Marseille | Provence-Alpes-Côte d'Azur Region | 13105 | France |
| Centre Leon Berard /ID# 160561 | Lyon | Rhone | 69373 | France |
| Centre Hosp Intercommunal de Creteil /ID# 162684 | Créteil | Val-de-Marne | 94000 | France |
| Assistance Publique- Hopitaux /ID# 160552 | Paris | 75020 | France |
| Hospital Pontchaillou /ID# 160555 | Rennes | 35033 | France |
| KH Martha-Maria Halle Dolau /ID# 158796 | Halle | Saxony-Anhalt | 06120 | Germany |
| Evangelische Lungenklinik Berl /ID# 159168 | Berlin | 13125 | Germany |
| Asklepios Fachkliniken M. Gaut /ID# 158791 | Gauting | 82131 | Germany |
| Lungen Clinic Grosshansdorf /ID# 158770 | Großhansdorf | 22927 | Germany |
| Thoraxklinik Heidelberg gGmbH /ID# 159169 | Heidelberg | 69126 | Germany |
| Klinikum Kassel /ID# 158788 | Kassel | 34125 | Germany |
| Klinik Loewenstein GmbH /ID# 159167 | Löwenstein | 74245 | Germany |
| General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165 | Athens | 11527 | Greece |
| Metropolitan Hospital /ID# 159162 | Athens | 18547 | Greece |
| University Hospital of Ioannin /ID# 159163 | Ioannina | 45500 | Greece |
| Euromedica General Clinic /ID# 159161 | Thessaloniki | 54645 | Greece |
| Torokbalinti Tudogyogyintezet /ID# 207053 | Budapest | Pest County | 2045 | Hungary |
| Semmelweis Egyetem /ID# 161197 | Budapest | 1085 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet /ID# 158967 | Budapest | 1122 | Hungary |
| Dup_Debreceni Egyetem Klinikai Központ /ID# 161209 | Debrecen | 4032 | Hungary |
| Veszprem Megyei Tuedoegyogyint /ID# 162607 | Farkasgyepű | 8582 | Hungary |
| Petz Aladar Megyei Oktato Korh /ID# 158978 | Győr | 9023 | Hungary |
| Matrai Gyogyintezet /ID# 158979 | Mátraháza | 3233 | Hungary |
| AUSL 8 Arezzo Ospedale San Don /ID# 160967 | Arezzo | 52100 | Italy |
| Istituto Europeo di Oncologia /ID# 158942 | Milan | 20141 | Italy |
| A.O.U. San Luigi Gonzaga /ID# 158945 | Orbassano | 10043 | Italy |
| Ospedale Santa Maria delle Cro /ID# 158940 | Ravenna | 48121 | Italy |
| IFO Istituto Nazionale Tumori /ID# 158941 | Rome | 00144 | Italy |
| Aichi Cancer Center Hospital /ID# 164975 | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East /ID# 165726 | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kyushu University Hospital /ID# 165723 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Kurume University Hospital /ID# 164586 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Hokkaido Cancer Center /ID# 165237 | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo Cancer Center /ID# 165125 | Akashi-shi | Hyōgo | 673-8558 | Japan |
| Himeji Medical Center /ID# 165893 | Himeji-shi | Hyōgo | 670-0012 | Japan |
| Duplicate_Kanazawa University Hospital /ID# 165129 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Yokohama City University Hospital /ID# 165748 | Yokohama | Kanagawa | 236-0004 | Japan |
| Kanagawa Cardiovascular and Respiratory Center /ID# 164374 | Yokohama | Kanagawa | 236-0051 | Japan |
| Sendai Kousei Hospital /ID# 166061 | Sendai | Miyagi | 980-0873 | Japan |
| Japanese Red Cross Okayama Hospital /ID# 165156 | Okayama | Okayama-ken | 700-8607 | Japan |
| Kansai Medical University Hospital /ID# 165055 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Osaka City General Hospital /ID# 165717 | Osaka | Osaka | 534-0021 | Japan |
| Kindai University Hospital /ID# 166394 | Osaka-sayama-shi | Osaka | 589-8511 | Japan |
| Shizuoka Cancer Center /ID# 166466 | Sunto-gun | Shizuoka | 411-8777 | Japan |
| Tokushima University Hospital /ID# 165812 | Tokushima | Tokushima | 770-8503 | Japan |
| National Cancer Center Hospital /ID# 166768 | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 166249 | Koto-ku | Tokyo | 135-8550 | Japan |
| Duplicate_Showa University Hospital /ID# 165574 | Shinagawa-ku | Tokyo | 142-0054 | Japan |
| Wakayama Medical University /ID# 166032 | Wakayama | Wakayama | 641-8510 | Japan |
| Matsusaka City Hospital /ID# 166126 | Matsusaka-shi MIE | 515-8544 | Japan |
| Kanagawa Cancer Center /ID# 165816 | Yokohama | 241-0815 | Japan |
| Pauls Stradins Clinical /ID# 158713 | Riga | LV-1002 | Latvia |
| Riga East Clinical University /ID# 158714 | Riga | LV-1079 | Latvia |
| Centro de Investigación Clinica Chapultepec /ID# 161000 | Morelia | Michoacán | 58260 | Mexico |
| Health Pharma Professional Research S.A de C.V /ID# 160020 | Del. Benito Juárez | 03810 | Mexico |
| Universitair Medisch Centrum Groningen /ID# 158088 | Groningen | 9713 GZ | Netherlands |
| Ziekenhuis St. Jansdal /ID# 158652 | Harderwijk | 3844 DG | Netherlands |
| Isala /ID# 158653 | Zwolle | 8025 AB | Netherlands |
| Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537 | Rzeszów | Podkarpackie Voivodeship | 35-021 | Poland |
| Copernicus PL Sp. z o. o., WCO /ID# 160538 | Gdansk | 80-219 | Poland |
| Szpitale Pomorskie Sp. z o.o /ID# 160536 | Gdynia | 81-519 | Poland |
| Centro Hospitalar Lisboa Norte, EPE /ID# 158687 | Lisbon | Lisbon District | 1769-001 | Portugal |
| IPO Lisboa FG, EPE /ID# 158995 | Lisbon | 1099-023 | Portugal |
| Hospital da Luz, SA /ID# 158996 | Lisbon | 1500-650 | Portugal |
| Unidade Local Saude Matosinhos /ID# 158682 | Matosinhos Municipality | 4464-513 | Portugal |
| Hospital CUF Porto /ID# 158685 | Porto | 4100-180 | Portugal |
| IPO Porto FG, EPE /ID# 158686 | Porto | 4200-072 | Portugal |
| S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847 | Craiova | Dolj | 200347 | Romania |
| Oncocenter Oncologie Clinica S /ID# 160848 | Timișoara | Timiș County | 300166 | Romania |
| Spitalul Judetean de Urgenta A /ID# 160846 | Alba | 510077 | Romania |
| National Medical Research Cntr /ID# 207436 | Moscow | Moscow Oblast | 115478 | Russia |
| LLC Novaya Klinika /ID# 205539 | Pyatigorsk | Stavropol Kray | 357500 | Russia |
| Arkhangelsk clinical oncology /ID# 159309 | Arkhangelsk | 163045 | Russia |
| Kaluga Regional Clinical Oncol /ID# 160179 | Kaluga | 284007 | Russia |
| Clinical Onco Dispensary /ID# 159307 | Omsk | 644013 | Russia |
| PMI Euromedservice /ID# 159311 | Pushkin | 196603 | Russia |
| LLC BioEq Ltd. /ID# 159310 | Saint Petersburg | 197342 | Russia |
| N.N. Petrov Research Inst Onc /ID# 159312 | Saint Petersburg | 197758 | Russia |
| Smolensk Regional Onc Clin Dis /ID# 159314 | Smolensk | 214009 | Russia |
| Clinical Center of Nis /ID# 160059 | Niš | Nisavski Okrug | 18000 | Serbia |
| Institut za onkologiju i radio /ID# 160058 | Belgrade | 11000 | Serbia |
| Klinicki centar Srbije /ID# 160024 | Belgrade | 11000 | Serbia |
| Institute For Pulmonary Diseas /ID# 158813 | Kamenitz | 21204 | Serbia |
| National University Hospital /ID# 158802 | Singapore | 119074 | Singapore |
| National Cancer Ctr Singapore /ID# 158803 | Singapore | 169610 | Singapore |
| Dong-A University Hospital /ID# 159296 | Busan | Busan Gwang Yeogsi | 49201 | South Korea |
| CHA Bundang Medical center CHA University /ID# 204416 | Seongnam-si | Gyeonggido | 13496 | South Korea |
| Chonnam National University Hospital /ID# 159294 | Gwangju | Jeonranamdo | 61469 | South Korea |
| Kyungpook National University Chilgok Hospital /ID# 159292 | Daegu | Seoul Teugbyeolsi | 41404 | South Korea |
| Yonsei University Health System, Severance Hospital /ID# 159288 | Seodaemun-gu | Seoul Teugbyeolsi | 03722 | South Korea |
| Korea University Guro Hospital /ID# 159293 | Seoul | Seoul Teugbyeolsi | 08308 | South Korea |
| Chungbuk National University /ID# 159291 | Cheongju-si | 28644 | South Korea |
| Asan Medical Center /ID# 159290 | Seoul | 05505 | South Korea |
| Hospital Clinic /ID# 159031 | Barcelona | 08036 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 159028 | Barcelona | 08041 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 159025 | Madrid | 28007 | Spain |
| Hospital Universitario HM Sanchinarro /ID# 159024 | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 159027 | Valencia | 46010 | Spain |
| Sahlgrenska US Gbg /ID# 159534 | Gothenburg | Västra Götaland County | 413 46 | Sweden |
| Uppsala University Hospital /ID# 159050 | Uppsala | 75185 | Sweden |
| National Cheng Kung University Hospital /ID# 158844 | Tainan | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital /ID# 158865 | Taipei City | Taipei | 100 | Taiwan |
| Tri-Service General Hospital /ID# 158985 | Taipei City | Taipei | 11490 | Taiwan |
| Taichung Veterans General Hosp /ID# 158866 | Taichung | 40705 | Taiwan |
| Hacettepe University Medical Faculty /ID# 159238 | Altindağ | Ankara | 06250 | Turkey (Türkiye) |
| Inonu Universitesi Turgut Ozal /ID# 159241 | Battalgazi/malatya | 44280 | Turkey (Türkiye) |
| Ege University Medical Faculty /ID# 159239 | Izmir | 35040 | Turkey (Türkiye) |
| Dr. Suat Seren Gogus Has /ID# 159240 | Izmir | 35110 | Turkey (Türkiye) |
| Ataturk Gogus Hastaliklari ve /ID# 160056 | Kecioren/ankara | 06280 | Turkey (Türkiye) |
| CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122 | Zaporizhzhia | Zaporizhzhia Oblast | 69040 | Ukraine |
| Municipal institution /ID# 159867 | Chernivtsi | 58013 | Ukraine |
| Municipal institution Multifie /ID# 159121 | Dnipro | 49102 | Ukraine |
| Regional Center of Oncology /ID# 159123 | Kharkiv | 61070 | Ukraine |
| PE PMC Acinus, Medical and Diagnostic Center /ID# 159125 | Kropyvnytskyi | 25006 | Ukraine |
| ME Kryviy Rih Oncology Dispensary /ID# 159119 | Kryviy RIH | 50048 | Ukraine |
| Volyn Regional Medical Oncology Centre /ID# 159124 | Lutsk | 43018 | Ukraine |
| Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868 | Uzhhorod | 88000 | Ukraine |
| Guy's and St Thomas' NHS Found /ID# 159581 | London | London, City of | SE1 9RT | United Kingdom |
| United Lincolnshire Hospitals /ID# 159579 | Boston | PE21 9QS | United Kingdom |
| Charing Cross Hospital /ID# 159582 | London | W6 8RF | United Kingdom |
| Christie NHS Foundation Trust /ID# 159099 | Manchester | M20 4BX | United Kingdom |
| James Cook University Hospital /ID# 159583 | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Preston Hospital /ID# 159578 | Preston | PR2 9HT | United Kingdom |
| Derived |
| Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22. |
| COMPLETED | Participants who were off study as of 04 December 2019. |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Topotecan | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle. |
| BG001 | Rovalpituzumab Tesirine | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method. | Randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the number of months from the date of randomization until the date of first progression or the date of a participant's death, whichever occurs first. If a participant neither experienced disease progression nor died, then the participant's data were censored at the last date of radiographic assessment that they were documented to be progression free. Calculated using the Kaplan-Meier product-limit method. Radiographic tumor assessments for response were conducted by CT scanning according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions. | Randomized participants | Posted | Median | 95% Confidence Interval | months | From randomization until the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of the Physical Functioning Scale Score in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC QLQ-C15-PAL) at Week 7 | The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC core quality of life questionnaire (EORTC QLQ-C30) developed for use in palliative care. The score of 'physical functioning scale' score ranges from 0 (very poor) to 100 (excellent). | Randomized participants with an assessment at baseline and Week 7. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Week 7 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Randomized participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | CBR is defined as percentage of participants whose best overall response is CR, PR, or stable disease (SD) according to RECIST version 1.1. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR, PR, or SD, including those who did not have post-baseline radiological assessments were considered as experiencing no clinical benefit. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. | Randomized participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Response (DOR) | DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first. Radiographic tumor assessments for response were conducted by CT scanning, and assessed from the date of randomization until disease progression or death, whichever came first. Any participant who did not meet CR or PR, including those who did not have post-baseline radiological assessments were considered non-responders. CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Randomized participants with measurable disease at baseline, and a response. | Posted | Median | 95% Confidence Interval | months | Radiographic tumor assessments were conducted at baseline, every 6 weeks for 30 weeks, then every 9 weeks until progression or death; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. |
|
All-cause mortality is reported from enrollment to the end of study; median time on follow-up was 20 and 20.6 months for the topotecan and rovalpituzumab tesirine arms, respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 14.8 weeks and 11.3 weeks for the topotecan and rovalpituzumab tesirine arms, respectively.
All-cause mortality: all randomized participants. Adverse events: all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topotecan | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m^2 on Days 1 to 5 of each 21-day cycle. | 115 | 148 | 74 | 129 | 118 | 129 |
| EG001 | Rovalpituzumab Tesirine | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. | 262 | 296 | 160 | 287 | 245 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMATOTOXICITY | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ARRHYTHMIA | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CARDIAC TAMPONADE | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| APLASIA | Congenital, familial and genetic disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUBILEUS | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| POLYSEROSITIS | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEROSITIS | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLANGITIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHOLESTASIS | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DRUG-INDUCED LIVER INJURY | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| LUNG ABSCESS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPENIC SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA NECROTISING | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA STAPHYLOCOCCAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SALMONELLOSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| EYELID CONTUSION | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| HEAT STROKE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| THERMAL BURN | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| CULTURE URINE POSITIVE | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| GENERAL PHYSICAL CONDITION ABNORMAL | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| GASTROINTESTINAL NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| INFECTED NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM OF SPINAL CORD | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| METASTASES TO MENINGES | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| SMALL CELL LUNG CANCER METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| TUMOUR NECROSIS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CERVICAL CORD COMPRESSION | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EMBOLIC STROKE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTRACRANIAL PRESSURE INCREASED | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTRAVENTRICULAR HAEMORRHAGE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NERVOUS SYSTEM DISORDER | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE LUNG INJURY | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHRONIC RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DYSPNOEA AT REST | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PLEURISY | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| SUPERIOR VENA CAVA SYNDROME | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 22.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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| PHOTOSENSITIVITY REACTION | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 13, 2020 | Jan 29, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620223 | rovalpituzumab tesirine |
| D019772 | Topotecan |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
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Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
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