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Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Lurbinectedin (PM01183) / Doxorubicin |
|
| Control Arm 1 | Active Comparator | CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR)) |
|
| Control Arm 2 | Active Comparator | Topotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurbinectedin (PM01183) | Drug |
| ||
| Doxorubicin (DOX) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Every three months up to death or study termination, a period of approximately 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | At 12 months |
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Inclusion Criteria:
Exclusion Criteria:
More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
Prior treatment with PM01183, topotecan or anthracyclines.
Limited-stage patients who are candidates for local or regional therapy
Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization
Concomitant diseases/conditions:
Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
Pregnant or breast feeding women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35243 | United States | ||
| Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36252599 | Derived | Aix SP, Ciuleanu TE, Navarro A, Cousin S, Bonanno L, Smit EF, Chiappori A, Olmedo ME, Horvath I, Grohe C, Farago AF, Lopez-Vilarino JA, Cullell-Young M, Nieto A, Vasco N, Gomez J, Kahatt C, Zeaiter A, Carcereny E, Roubec J, Syrigos K, Lo G, Barneto I, Pope A, Sanchez A, Kattan J, Zarogoulidis K, Waller CF, Bischoff H, Juan-Vidal O, Reinmuth N, Domine M, Paz-Ares L. Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial. Lancet Respir Med. 2023 Jan;11(1):74-86. doi: 10.1016/S2213-2600(22)00309-5. Epub 2022 Oct 14. |
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The first randomization took place on 30 August 2016 and the first study treatment was administered on 25 October 2016. The cutoff date for results presented in this Clinical Study Report was 24 February 2020.
A total of 919 patients were screened; 613 of these 919 patients were randomized at a 1:1 ratio to receive any of the study treatments at 135 investigational sites from 20 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lurbinectedin/Doxorubicin | Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL. The combination was to be administered for up to a maximum of ten cycles. |
| 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 | May 3, 2018 | Apr 26, 2021 |
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|
| Cyclophosphamide (CTX) | Drug |
|
| Vincristine (VCR) | Drug |
|
| Topotecan | Drug |
|
| Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | At 18 months |
| Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | At 24 months |
| Progression-free Survival (PFS) by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Every six weeks up to progression disease, a period of approximately 3.5 years |
| Progression-free Survival Rate at 6 Months by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | At 6 months |
| Progression-free Survival Rate at 12 Months by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | at 12 months |
| Best Antitumor Response by Independent Review Committee | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Response Rate by Independent Review Committee | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Duration of Response by Independent Review Committee | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Every three months up to death or study termination, a period of approximately 3.5 years |
| Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Every six weeks up to progression disease, a period of approximately 3.5 years |
| Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Survival in Patients With Chemotherapy-free Interval < 90 Days | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Every three months up to death or study termination, a period of approximately 3.5 years |
| Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Every six weeks up to progression disease, a period of approximately 3.5 years |
| Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Duration of Response in Patients With Chemotherapy-free Interval <90 Days | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Survival in Patients Without Central Nervous System Involvement at Baseline | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Every three months up to death or study termination, a period of approximately 3.5 years |
| Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Every six weeks up to progression disease, a period of approximately 3.5 years |
| Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Duration of Response in Patients Without Central Nervous System Involvement at Baseline | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Survival in Patients With Central Nervous System Involvement at Baseline | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Every three months up to death or study termination, a period of approximately 3.5 years |
| Progression-free Survival in Patients With Central Nervous System Involvement at Baseline | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Every six weeks up to progression disease, a period of approximately 3.5 years |
| Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Overall Response Rate in Patients With Central Nervous System Involvement at Baseline | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Duration of Response in Patients With Central Nervous System Involvement at Baseline | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Every three months up to death or study termination, a period of approximately 3.5 years |
| Chandler |
| Arizona |
| 85224 |
| United States |
| St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare | Fullerton | California | 92835 | United States |
| Loma Linda University Medica! Center | Loma Linda | California | 92354 | United States |
| Innovative Clinical Research Institute (ICRI) | Whittier | California | 90603 | United States |
| Boca Raton Regional Hospital Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | 33308 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Healthcare Research Network III, LLC | Tinley Park | Illinois | 60487 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Montgomery Cancer Center | Mount Sterling | Kentucky | 40353 | United States |
| East Jefferson Hematology-Oncology Metairie Physicians Services, Inc | Metairie | Louisiana | 70006 | United States |
| Anne Arundel Medical Center Oncology and Hematology | Annapolis | Maryland | 21401 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| QUEST Research Institute | Royal Oak | Michigan | 48073 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital | Lebanon | New Hampshire | 03756 | United States |
| Summit Medical Group, P.A. | Florham Park | New Jersey | 07932 | United States |
| FirstHealth Outpatient Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| Oklahoma Cancer Specialists and Research Institute, LLC | Tulsa | Oklahoma | 74146 | United States |
| Associates in Hematology and Oncology, P.C. | Upland | Pennsylvania | 19013 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Tyler Hematology-Oncology PA | Tyler | Texas | 75701 | United States |
| Medical Oncology Associates PS (dba Summit Cancer Centers) | Spokane | Washington | 99208 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Instituto Médico Especializado Alexander Fleming | C.a.b.a. | Buenos Aires | C1426ANZ | Argentina |
| Centro para la Atención Integral del Paciente Oncológico (CAIPO) | San Miguel de Tucumán | Tucumán Province | T4000GTB | Argentina |
| Instituto Oncológico de Córdoba (IONC) | Córdoba | X5000HLX | Argentina |
| CORI - Centro Oncológico Riojano Integral | La Rioja | F5300COE | Argentina |
| ISIS Centro Especializado de Luce S.A. | Santa Fe | S3000FFU | Argentina |
| Universitätsklinik für Innere Medizin III der PMU | Salzburg | 5020 | Austria |
| Medizinische Universität Wien / AKH Wien, Universitätsklinik für Innere Medizin I, Abteilung für klinische Onkologie | Vienna | 1090 | Austria |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Clinique André Renard | Herstal | 4040 | Belgium |
| CHR de la citadelle | Liège | 4000 | Belgium |
| CHU de Liege - Sart Tilman | Liège | 4000 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| AZ Delta Campus Wilgenstraat | Roeselare | 8800 | Belgium |
| Nucleo de Oncologia da Bahia | Salvador | Estado de Bahia | 40170-110 | Brazil |
| lOP- Instituto de oncologia do paraná | Curitiba | Paraná | 80530-010 | Brazil |
| Coordenação de Pesquisa Clínica / Instituto Nacional de Câncer | Rio de Janeiro | Rio de Janeiro | 20231-092 | Brazil |
| Instituto COl de Pesquisa, Educação e Gestão | Rio de Janeiro | Rio de Janeiro | 22793-080 | Brazil |
| Associação Hospital de Caridade de Ijuí | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| lrmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital São Lucas da PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de clínicas de Porto alegre | Pôrto Alegre | Rio Grande do Sul | 90.035-903 | Brazil |
| Fundação PlO XII - Hospital de Câncer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas | São Paulo | São Paulo | 01236-030 | Brazil |
| Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte | Panagyurishte | 4500 | Bulgaria |
| Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology | Sofia | 1330 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia | Sofia | 1431 | Bulgaria |
| Acibadem City Clinic University Multiprofile Hospital for Active Treatment. EOOD, Sofia; Clinic of Medical Oncology | Sofia | 1784 | Bulgaria |
| Southlake Regional Health Centre - Stronach Regional Cancer Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada |
| Centre intégré de santé et de services sociaux de la Montérégie Centre | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal Oncology Research Inc. | Montreal | Quebec | H1M 1B1 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Biron (Clinique René Laennec) | Mount Royal | Quebec | H3P 3H5 | Canada |
| Vitkovicka nemocnice, a.s., Plicni oddeleni | Ostrava | 703 84 | Czechia |
| Krajska zdravotni a.s. Masarykova nemocnice o.z. | Ústí nad Labem | 401 13 | Czechia |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre François Baclesse | Caen | 14076 | France |
| Centre Hospitalier Intercommunal de Créteil | Créteil | 94010 | France |
| Centre Hospitalier Lyon Sud - Service de Pneumologie | Lyon | 69310 | France |
| Hôpital Nord - Service Oncologie Multidisciplinaire et Innovations Thérapeutiques | Marseille | 13915 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| CHU de Rennes Hôpital Pontchaillou | Rennes | 35033 | France |
| Central Clinic of Bad Berka | Bad Berka | 99437 | Germany |
| Vivantes Klinikum am Urban, Hämatologie und Onkologie | Berlin | 10967 | Germany |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| Uniklinik Freiburg, Hämatologie, Onkologie & Stammzellransplantation | Freiburg im Breisgau | 79106 | Germany |
| Asklepios-Fachkliniken München Gauting | Gauting | 82131 | Germany |
| Center for Pneumology and Thoracic Surgery | Gerlingen | 70839 | Germany |
| Thoraxklinik Heidelberg GmbH | Heidelberg | 69126 | Germany |
| Lungenklinik Hemer | Hemer | 58675 | Germany |
| VIDIA Christliche Kliniken Karlsruhe | Karlsruhe | 76137 | Germany |
| Katholisches Klinikum Koblenz-Montabaur, Marienhof Koblenz | Koblenz | 56073 | Germany |
| Onkologische Schwerpunktpraxis Leer-Emden | Leer | 26789 | Germany |
| Klinik Löwenstein gGmbH, Med. Klinik II Onkologie | Löwenstein | 74245 | Germany |
| Uniklinikum Mannheim, TTZ, Medizinische Fakultät Mannheim | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie und Palliativmedizin | Minden | 32429 | Germany |
| University of Munich LMU, Dpt. of Medicine V | München | 80336 | Germany |
| Städtisches Krankenhaus München Neuperlach | München | 81737 | Germany |
| Klinikum Bogenhausen, Städt. Klinikum München GmbH, Klinik für Pneumologie und Pneumologische Onkologie | München | 81925 | Germany |
| Klinikum Nürnberg Nord - Pneumologische Onkologie | Nuremberg | 90419 | Germany |
| Universitätsklinikum Ulm - Klinik für Innere Medizin II, Pneumologie | Ulm | 89081 | Germany |
| Medizinische Klinik I | Wuppertal | 42283 | Germany |
| University General Hospital of Heraklion - General Hospital "Venizeleio" | Heraklion | Crete | 71110 | Greece |
| General Hospital of Chest Diseases of Athens "Sotiria" | Athens | 11527 | Greece |
| General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic | Athens | 14564 | Greece |
| General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki | Thessaloniki | 57010 | Greece |
| Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia | Budapest | 1121 | Hungary |
| Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia | Budapest | 1121 | Hungary |
| Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály | Farkasgyepű | 8582 | Hungary |
| Mátrai Gyógyintézet, Bronchológia | Mátraháza | 3233 | Hungary |
| Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály | Miskolc | 3529 | Hungary |
| Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály | Székesfehérvár | 8000 | Hungary |
| Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály | Szombathely | 9700 | Hungary |
| Szent Borbála Kórház, Pulmonológiai osztály | Tatabánya | 2800 | Hungary |
| Zala Megyei Kórház, Pulmonologia | Zalaegerszeg | 8900 | Hungary |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | MI | 20162 | Italy |
| IRCCS CROB (Istituto di Ricovero e Cura a Carattere Scientifico) | Rionero in Vulture | PZ | 85028 | Italy |
| Centro di Riferimento Oncologico di Aviano | Aviano | 33081 | Italy |
| Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico | Catania | 95123 | Italy |
| AOU Maggiore della Carità - SC Oncologia | Novara | 28100 | Italy |
| Istituto Oncologico Veneto | Padova | 35128 | Italy |
| lRCCS-Arcispedale Santa Maria Nuova | Reggio Emilia | 42123 | Italy |
| Policlinico Universitario Campus Bio-Medico | Roma | 00128 | Italy |
| ASST della Valtellina e dell' Alto Lario P.O. Di Sondrio | Sondrio | 23100 | Italy |
| Ain Wazein Hospital | Ain Wazein | El Chouf | Lebanon |
| American University of Beirut Medical Center | Beirut | Lebanon |
| Hotel Dieu de France | Beirut | Lebanon |
| Centre Hospitalier Universitaire Notre Dame de Secours | Byblos | Lebanon |
| Hammoud Hospital University Medical Center | Sidon | Lebanon |
| The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 CX | Netherlands |
| Spaarne Gasthuis | Hoofddorp | 2134 TM | Netherlands |
| MUMC | Maastricht | 6229 HX | Netherlands |
| Maxima Medisch Centrum | Veldhoven | 5504 DB | Netherlands |
| Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie; Oddzial Onkologii Klinicznej im. dr Ewy Pileckiej z pododdzialem | Bialystok | 15-027 | Poland |
| Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii Klinicznej, Oddzial Onkologii i Radioterapii | Gdynia | 81-519 | Poland |
| Mazowieckie Centrum Leczenia Chorób Pluc i Gruźlicy Oddzial III Chorób Pluc z Pododdzialem Onkologicznym | Otwock | 05-400 | Poland |
| Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. K.Marcinkowskiego w Poznaniu, Oddzial Chemioterapii | Poznan | 60-569 | Poland |
| Centro Clínico Champalimaud - Fundação Champalimaud | Lisbon | 1400-038 | Portugal |
| Centro Hospitalar Lisboa Norte, EPE- Hospital Pulido Valente | Lisbon | 1769-001 | Portugal |
| Centro Hospitalar do Porto, EPE - Hospital de Santo António | Porto | 4099-001 | Portugal |
| Hospital CUF Porto | Porto | 4100-180 | Portugal |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Porto | 4200-072 | Portugal |
| Centro Hospitalar de São João, EPE | Porto | 4200-319 | Portugal |
| SC Centrul de Oncologie Sf. Nectarie SRL, Departament Oncologie Medícala | Craiova | Dolj | 200347 | Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" | Constanța | Judet Constanta | 900591 | Romania |
| SC Oncolab SRL | Craiova | Judet Dolj | 200385 | Romania |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris", Sectia Oncologie Medicala | Baia Mare | Maramureş | 430031 | Romania |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Departament Oncologie Medicala | Cluj-Napoca | 400015 | Romania |
| Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Dcpartamentul Oncologie Medicala | Cluj-Napoca | 400015 | Romania |
| Institutul Oncologic "Prof. Dr. lon Chiricuta" Cluj-Napoca, Sectia Oncologic Medicala | Cluj-Napoca | 400015 | Romania |
| Hospital Universitari Germans Trias i Pujol ICO | Badalona | Barcelona | 08916 | Spain |
| Corporació Sanitaria Parc Taulí-Hospital de Sabadell | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Vall d' Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| MD Anderson Cancer Center Madrid | Madrid | 28033 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Complejo hospitalario regional virgen rocío | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| The Christie NHS Fundation Trust | Manchester | Greater Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington | Wirral | CH63 4JY | United Kingdom |
| Bristol Cancer Institute, UHB NHS Foundation Trust | Bristol | BS2 8ED | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Sarah Cannon Research Institute UK | London | W1G 6AD | United Kingdom |
| Worcestershire Acute Hospitals NHS Trust | Worcester | WR5 1DO | United Kingdom |
| FG001 | Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and Cyclophosphamide, Doxorubicin and Vincristine (CAV), until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lurbinectedin/Doxorubicin | Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL. The combination was to be administered for up to a maximum of ten cycles. |
| BG001 | Topotecan or Cyclophosphamide/Doxorubicin/Vincristine | If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
| 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 | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Median | Full Range | Kg |
| |||||||||||||||
| Height | Median | Full Range | cm |
| |||||||||||||||
| Body surface area | Median | Full Range | m^2 |
| |||||||||||||||
| Body mass index | Median | Full Range | Kg/m^2 |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance Status | Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead | Count of Participants | Participants |
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| Smoking status | Count of Participants | Participants |
| ||||||||||||||||
| Time from first diagnosis to randomization | Median | Full Range | months |
| |||||||||||||||
| Disease stage | Limited stage. Limited stage means that the cancer is only in 1 part of the chest and radiation therapy could be a treatment option. Extensive stage. Extensive stage is used to describe SCLC that has spread to other parts of the body such as the opposite lung, bone, brain, or bone marrow. | Count of Participants | Participants |
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| Number of sites involved | Count of Participants | Participants |
| ||||||||||||||||
| Number of sites involved | Median | Full Range | sites |
| |||||||||||||||
| Bulky disease | Bulky disease defined as one lesion ≥50 mm | Count of Participants | Participants |
| |||||||||||||||
| Central Nervous System involvement | Count of Participants | Participants |
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| Paraneoplastic syndrome | Count of Participants | Participants |
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| Prior radiotherapy | Count of Participants | Participants |
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| Prior surgery | Count of Participants | Participants |
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| Lines of anticancer therapy | Median | Full Range | lines of therapies |
| |||||||||||||||
| Best response to last prior chemotherapy | Complete response (CR): disappearance of all lesions; Partial response (PR): ≥10% decrease in target lesion size or ≥15% decrease in tumor density; Disease progression (PD): ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; Stable disease (SD): none of the CR, PR, or PD criteria met; Unknown (UK) | Count of Participants | Participants |
| |||||||||||||||
| Prior immunotherapy against PD-1 or PD-L1 | PD-1, programmed cell death protein-1; PD-L1, programmed death ligand-1 | Count of Participants | Participants |
| |||||||||||||||
| Time-to-progression to prior chemotherapy | Median | Full Range | months |
| |||||||||||||||
| Time from last prior progressive disease to randomization | Median | Full Range | days |
| |||||||||||||||
| Time from end date of last prior chemotherapy to randomization | Median | Full Range | days |
| |||||||||||||||
| Chemotherapy-free interval | Median | Full Range | days |
| |||||||||||||||
| Chemotherapy-free interval | 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) | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice | Posted | Number | 95% Confidence Interval | percentage of participants | At 12 months |
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| Secondary | Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice | Posted | Number | 95% Confidence Interval | percentage of participants | At 18 months |
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| Secondary | Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | Patients with Cyclophosphamide, Doxorubicin and Vincristine (CAV) as best Investigator's choice | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 months |
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| Secondary | Progression-free Survival (PFS) by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Posted | Median | 95% Confidence Interval | months | Every six weeks up to progression disease, a period of approximately 3.5 years |
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| Secondary | Progression-free Survival Rate at 6 Months by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | At 6 months |
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| Secondary | Progression-free Survival Rate at 12 Months by Independent Review Committee | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | Posted | Number | 95% Confidence Interval | percentage of participants | at 12 months |
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| Secondary | Best Antitumor Response by Independent Review Committee | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Posted | Count of Participants | Participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Response Rate by Independent Review Committee | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Posted | Number | 95% Confidence Interval | percentage of participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Duration of Response by Independent Review Committee | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Patients who have a partial or complete response in the best antitumor response | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy | Posted | Median | 95% Confidence Interval | months | Every six weeks up to progression disease, a period of approximately 3.5 years |
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| Secondary | Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy | Posted | Count of Participants | Participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy | Posted | Number | 95% Confidence Interval | percentage of participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval ≥90 days after first-line chemotherapy. | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Survival in Patients With Chemotherapy-free Interval < 90 Days | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval <90 days after first-line chemotherapy | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval <90 days after first-line chemotherapy | Posted | Median | 95% Confidence Interval | months | Every six weeks up to progression disease, a period of approximately 3.5 years |
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| Secondary | Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval <90 days after first-line chemotherapy | Posted | Count of Participants | Participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval <90 days after first-line chemotherapy | Posted | Number | 95% Confidence Interval | percentage of participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Duration of Response in Patients With Chemotherapy-free Interval <90 Days | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients had chemotherapy-free interval <90 days after first-line chemotherapy. | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Survival in Patients Without Central Nervous System Involvement at Baseline | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every six weeks up to progression disease, a period of approximately 3.5 years |
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| Secondary | Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline | Posted | Count of Participants | Participants | Every three months up to death or study termination, a period of approximately 3.5 years |
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| Secondary | Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Every three months up to death or study termination, a period of approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in Patients Without Central Nervous System Involvement at Baseline | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients without Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival in Patients With Central Nervous System Involvement at Baseline | Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date). | A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival in Patients With Central Nervous System Involvement at Baseline | Progression-free survival (PFS) is defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient receives further antitumor therapy or is lost to follow-up before PD, PFS will be censored at the date of last tumor assessment before the date of subsequent antitumor therapy. | A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every six weeks up to progression disease, a period of approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline | Best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline | Posted | Count of Participants | Participants | Every three months up to death or study termination, a period of approximately 3.5 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate in Patients With Central Nervous System Involvement at Baseline | Overall response rate is defined as the proportion of patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline | Posted | Number | 95% Confidence Interval | percentage of participants | Every three months up to death or study termination, a period of approximately 3.5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response in Patients With Central Nervous System Involvement at Baseline | Duration of Response is defined as the time that patients who have a partial or complete response in the best antitumor response. The best antitumor response will be the best response obtained in any evaluation according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown | Patients who have a partial or complete response in the best antitumor response. A preplanned exploratory efficacy subgroup analysis was focused on patients with Central Nervous System Involvement at Baseline | Posted | Median | 95% Confidence Interval | months | Every three months up to death or study termination, a period of approximately 3.5 years |
|
Patients were assessed through study completion, approximately 2 years
21 of 613 randomized patients did not receive the study treatment. Safety population consisted of 592 treated patients. 302 had been randomized to lurbinectedin/DOX and 290 to topotecan or CAV. However, one patient randomized to receive topotecan was treated with lurbinectedin/DOX instead. For safety data analysis, this patient has been moved to the lurbinectedin/DOX Arm, and the safety population thereby comprised 303 patients with lurbinectedin/DOX and 289 patients with topotecan or CAV.
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 | Lurbinectedin/Doxorubicin | Doxorubicin: 40.0 mg/m2 i.v. on Day 1 through peripheral or central lines (according to local label), followed by, Lurbinectedin: 2.0 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines. A minimum volume of 100 mL diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL. The combination was to be administered for up to a maximum of ten cycles. | 264 | 303 | 126 | 303 | 292 | 303 |
| EG001 | Topotecan | If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
| 100 | 121 | 66 | 121 | 120 | 121 |
| EG002 | Cyclophosphamide/Doxorubicin/Vincristine | If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
| 148 | 168 | 75 | 168 | 148 | 168 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Optic atrophy | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Central pain syndrome | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mediastinal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit. | Pharma Mar S.A. | 0034 918466000 | clinicaltrials@pharmamar.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2020 | Jul 9, 2021 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C568606 | PM 01183 |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002166 | Camptothecin |
Not provided
Not provided
| 50-65 years |
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| >65 years |
|
| Male |
|
| Black or African American |
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| Asian |
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| Other |
|
| Not available |
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| Romania |
|
| Hungary |
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| United States |
|
| Czechia |
|
| United Kingdom |
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| Portugal |
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| Spain |
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| Greece |
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| Lebanon |
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| Canada |
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| Austria |
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| Netherlands |
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| Belgium |
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| Brazil |
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| Poland |
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| Italy |
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| Bulgaria |
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| France |
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| Germany |
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| PS 1 |
|
| PS 2 |
|
| Current |
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| Never |
|
| Extensive |
|
| ≥3 sites |
|
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|
| Unknown |
|
| 90-179 days |
|
| ≥180 days |
|
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If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
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If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.
Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or
CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
| OG001 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
|
|
|
|
|
|
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.
Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or
CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
| OG001 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
|
|
|
|
|
|
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.
Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or
CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
| OG001 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
|
|
|
|
|
|
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option.
Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or
CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
|
|
|
|
| OG001 |
| Topotecan or Cyclophosphamide/Doxorubicin/Vincristine |
If the patient was randomized to the Control Arm, the assigned treatment was based on the reported Investigator's preference between topotecan and CAV, until the first of these options had reached 55% of the target patient enrollment in this arm. Once this had occurred, patients in the Control Arm were to receive the other option. Topotecan: i.v. daily on Days 1-5 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines (according to local label) at the following doses:
or CAV: i.v. on Day 1 q3wk (three weeks ±48h = one treatment cycle) through peripheral or central lines at the following doses:
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