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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004261-26 | EudraCT Number |
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A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy
The study was conducted in two parts:
The study was conducted in two parts:
Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were planned to be enrolled.
Part 1 Primary Objectives:
Part 2: A randomized, efficacy study of irinotecan liposome injection versus intravenous (IV) topotecan.
Approximately 450 patients were planned to be enrolled in part 2.
Part 2 objectives: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Experimental Arm, dose level 1 | Experimental | Irinotecan liposome injection |
|
| Part 1: Experimental Arm, dose level 2 | Experimental | Irinotecan liposome injection |
|
| Part 2: Experimental Arm | Experimental | Irinotecan liposome injection |
|
| Part 2: Control Arm | Active Comparator | Topotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposome injection | Drug | IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenital anomaly or birth defect; or was medically important. A TEAE was any AE that occurred or worsened on or after the day of first dose of study treatment and within 30 days after discontinuation of study treatment. | The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days |
| Part 1: Number of Participants With Dose-Limiting Toxicities (DLT) | A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor. | From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days |
| Part 2: Overall Survival (OS) | The OS was defined as the time from randomization date to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status. | From date of randomization (within 7 days before start of study treatment) until death. Assessed up to Part 2 primary analysis DCO date of 08 February 2022 (approximately 900 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective Response Rate (ORR) | The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) recorded from date of first dose of study treatment until documented PD or death. ORR analysis was based on BOR using RECIST v1.1 per investigator assessment. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had computed tomography (CT)-scans and brain magnetic resonance imaging (MRI) every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. |
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Inclusion Criteria:
At least 18 years of age.
Able to understand and provide an informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy >12 weeks
Histopathologically or cytologically confirmed small cell lung cancer
Evaluable disease as defined by RECIST Version 1.1 guidelines (patients with non measurable lesions only are eligible).
Radiologically confirmed progression on or after first-line platinum based chemotherapy (carboplatin or cisplatin), or chemo-radiation including platinum-based chemotherapy for treatment of limited or extensive stage Small Cell Lung Cancer (SCLC). In addition to platinum-based regimen, one line of immunotherapy as monotherapy or in combination, in first or in second line setting is allowed.
Recovered from the effects of any prior chemotherapy, surgery, radiotherapy or other anti-neoplastic therapy (recovered to Grade 1 or better, with the exception of alopecia, peripheral neuropathy, or ototoxicity).
Adequate bone marrow reserves
Adequate hepatic function
Adequate renal function
Electrocardiogram during the Screening period without any clinically significant findings, per investigator's assessment
Patients with certain types of asymptomatic CNS metastases that meet ALL the following criteria are eligible.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| Rocky Mountain Cancer Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38648575 | Derived | Spigel DR, Dowlati A, Chen Y, Navarro A, Yang JC, Stojanovic G, Jove M, Rich P, Andric ZG, Wu YL, Rudin CM, Chen H, Zhang L, Yeung S, Benzaghou F, Paz-Ares L, Bunn PA; RESILIENT Trial Investigators. RESILIENT Part 2: A Randomized, Open-Label Phase III Study of Liposomal Irinotecan Versus Topotecan in Adults With Relapsed Small Cell Lung Cancer. J Clin Oncol. 2024 Jul 1;42(19):2317-2326. doi: 10.1200/JCO.23.02110. Epub 2024 Apr 22. | |
| 35195913 |
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Each part consisted of screening stage (up to 28 days), treatment/active follow-up stage, and a long-term monthly follow-up stage. A total of 30 participants in Part 1 received study treatment and 461 participants in Part 2 were randomized to receive study treatment in this study.
This Phase III, 2-part (Part 1: [open-label, single-arm dose evaluation period] and Part 2 [randomized, open-label period]) study was conducted in participants with small cell lung cancer (SCLC) who progressed on or after platinum-based first-line therapy at 11 sites for Part 1 and 116 sites for Part 2 in the USA, Europe, Asia, Australia, Turkey and Brazil. First participant was enrolled on 25 April 2018 and primary analysis data cut-off (DCO) date was 08 February 2022 for Part 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Irinotecan Liposome Injection 85 Milligrams/Meter Square (mg/m^2) | Participants received irinotecan liposome injection 85 mg/m^2 intravenously (i.v.) over 90 minutes every 2 weeks in a 6-week cycle until disease progression (PD), death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Dose Evaluation (Up to Week 172) |
|
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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 | Oct 7, 2021 | Aug 17, 2023 |
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Open Label
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|
| Topotecan | Drug | IV |
|
| RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days |
| Part 1: Progression-Free Survival (PFS) | The PFS was defined as time from first dose of study treatment to the first documented objective PD using RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, progression is defined as at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days |
| Part 1: OS | The OS was defined as the time from first dose of study treatment to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status. | From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days) |
| Part 2: PFS | The PFS was defined as time from randomization to first documented objective PD using RECIST 1.1 (or response assessment in neuro-oncology brain metastases [RANO-BM] criteria for central nervous system [CNS] lesions) as assessed by blinded independent central review (BICR) or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| Part 2: ORR | The ORR was defined as percentage of participants with a BOR characterized as either a CR or PR, recorded from randomization until documented PD or death relative to the total number of participants. ORR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| Part 2: Median Duration of Response (DoR) | The DoR was defined as time from the first documented objective response (CR or PR, whichever was earlier) to the date of first documented PD or death due to any cause. The DoR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions and PR is >=30% decrease in the sum of the longest diameter of target lesions. The DoR was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| Part 2: Median Time to Objective Response (OR) | Time to OR as per RECIST v1.1 criteria according to BICR was defined as time from the date of randomization to the date of first documented objective tumor response (CR or PR, whichever was first). Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesion. Participants with a new anti-cancer therapy prior to OR were censored at the last tumor assessment prior to new anti-cancer therapy. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Scores range from 0-100 and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in dyspnea scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy. | Baseline (Day 1) and Week 12 |
| Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy. | Baseline (Day 1) and Week 12 |
| Denver |
| Colorado |
| 80218 |
| United States |
| Florida Cancer Specialists (South Region) | Fort Myers | Florida | 33916 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | United States |
| Cancer Treatment Centers of America-Georgia | Newnan | Georgia | 30265 | United States |
| Illinois Cancer Care, PC | Peoria | Illinois | 61615 | United States |
| Southern Maine Health Care | Biddeford | Maine | 04005 | United States |
| University of Maryland Medical Group | Baltimore | Maryland | 21201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48219 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| North Shore Hematology Oncology Associates, PC | East Setauket | New York | 11733 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Tri County Hematology & Oncology Associates, Inc | Massillon | Ohio | 44646 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Charleston Hematology Oncology Associates, PA | Charleston | South Carolina | 29414 | United States |
| Greenville Hospital System University Medical Center | Greenville | South Carolina | 29605 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| MultiCare Health System Institute for Research and Innovation | Spokane | Washington | 99204 | United States |
| Summit Cancer Treatment Center | Spokane | Washington | 99208 | United States |
| Border Medical Oncology Research Unit | Albury | New South Wales | 2640 | Australia |
| South West Healthcare | Warrnambool | Victoria | 3280 | Australia |
| Southern Medical Day Care Centre | Wollongong | Australia |
| Princess Alexandra Hospital | Woolloongabba | Australia |
| AZ Klina | Brasschaat | Belgium |
| UZ Leuven | Leuven | Belgium |
| Centre Hospitalier de l'Ardenne | Libramont | Belgium |
| AZ Sint-Maarten | Mechelen | Belgium |
| Hospital de Cancer de Barretos, Fundacoa Pio X II | Barretos | Brazil |
| Hospital de Caridade de Ijuí | Ijuí | Brazil |
| Oncobio Servicos de Saude | Nova Lima | Brazil |
| HGB - Hospital Giovanni Battista - Mãe de Deus Center | Porto Alegre | Brazil |
| Hospital Nossa Senhora da Conceição | Porto Alegre | Brazil |
| INCA - Instituto Nacional de Câncer | Rio de Janeiro | Brazil |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo André | Brazil |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | Brazil |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | 233004 | China |
| The First Hospital of Jilin University | Changchun | 450008 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Guangdong Provincial People's Hospital | Guangzhou | 510080 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Tongji Hospital | Hubei | 430030 | China |
| Linyi Cancer Hospital | Linyi | China |
| Henan Cancer Hospital | Zhengzhou | China |
| CHU Brest - Hôpital Morvan | Brest | France |
| Hôpital Nord - CHU Marseille | Marseille | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | France |
| Centre Hospitalier de Saint-Quentin | Saint-Quentin | 02321 | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Evangelisches Krankenhaus Hamm GmbH | Hamm | 50063 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Semmelweis Egyetem | Budapest | Hungary |
| Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | Hungary |
| Zala Megyei Szent Rafael Korhaz | Zalaegerszeg | Hungary |
| Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori | Meldola | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy |
| Azienda Sanitaria Universitaria Integrata di Udine | Udine | Italy |
| KO-MED Centra Kliniczne Biala Podlaska | Biała Podlaska | Poland |
| Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością | Gdynia | Poland |
| SP Zespol Gruzlicy i Chorob Pluc w Olsztynie | Olsztyn | Poland |
| Przychodnia Med-Polonia Sp. z o.o. | Poznan | Poland |
| Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego | Poznan | Poland |
| S.C Gral Medical S.R.L | Bucharest | Romania |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca | Cluj-Napoca | Romania |
| S.C Medisprof S.R.L | Cluj-Napoca | Romania |
| S.C Centrul de Oncologie Sf. Nectarie S.R.L | Craiova | Romania |
| S.C Radiotherapy Center Cluj S.R.L | Floreşti | Romania |
| Oncomed SRL | Timișoara | Romania |
| SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" | Arkhangelsk | Russia |
| "VitaMed" LLC | Moscow | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary" | Omsk | Russia |
| SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary" | Saint Petersburg | 197022 | Russia |
| SPb SBIH "City Clinical Oncological Dispensary" | Saint Petersburg | Russia |
| SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" | Yaroslavl | Russia |
| Clinical Center "Bezanijska kosa" | Belgrade | Serbia |
| Clinical Center Kragujevac | Belgrade | Serbia |
| Oncomed System | Belgrade | Serbia |
| Institute for Pulmonary Diseases of Vojvodina | Kamenitz | Serbia |
| General Hospital Uzice | Užice | 31000 | Serbia |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Asan Medical Center | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | South Korea |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital General Universitario de Alicante | Alicante | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Changhua Christian Hospital | Changhua | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | 333 | Taiwan |
| Baskent University Adana Application and Research Center | Adana | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | Turkey (Türkiye) |
| Istanbul Medeniyet Uni Goztepe Training&Res Hosp | Istanbul | Turkey (Türkiye) |
| Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty | Istanbul | Turkey (Türkiye) |
| Inonu Uni. Med. Fac. | Malatya | Turkey (Türkiye) |
| Namik Kemal University | Tekirdağ | Turkey (Türkiye) |
| CI Chernivtsi RC Oncological Dispensary | Chernivtsi | Ukraine |
| CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipro | Ukraine |
| Communal Non-profit Enterprise Regional Center of Oncology | Kharkiv | 61070 | Ukraine |
| Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council | Kremenchuk | 39617 | Ukraine |
| CI Kryvyi Rih Oncological Dispensary of DRC | Kryvyi Rih | Ukraine |
| Treatment-Prevention Institution Volyn Regional Oncological Dispensary | Lutsk | Ukraine |
| Odesa Regional Oncologic Dispensary | Odesa | Ukraine |
| RCI Sumy Regional Clinical Oncological Dispensary | Sumy | Ukraine |
| CCCH City Oncological Center SHEI Uzhgorod NU | Uzhhorod | 88000 | Ukraine |
| Medical Clinic Innovacia, LLC | Vyshhorod | 07352 | Ukraine |
| Derived |
| Paz-Ares L, Spigel DR, Chen Y, Jove M, Juan-Vidal O, Rich P, Hayes T, Calderon VG, Caro RB, Navarro A, Dowlati A, Zhang B, Moore Y, Yao X, Kokhreidze J, Ponce S, Bunn PA. RESILIENT part 1: a phase 2 dose-exploration and dose-expansion study of second-line liposomal irinotecan in adults with small cell lung cancer. Cancer. 2022 May 1;128(9):1801-1811. doi: 10.1002/cncr.34123. Epub 2022 Feb 23. |
| Part 1: Irinotecan Liposome Injection 70 mg/m^2 |
Participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| FG002 | Part 2: Irinotecan Liposome Injection 70 mg/m^2 | Eligible participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| FG003 | Part 2: Topotecan 1.5 mg/m^2 | Eligible participants received topotecan 1.5 mg/m^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2: Randomized Study (Upto Week 197) |
|
|
Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. Part 2: Intent-to-Treat (ITT) population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Irinotecan Liposome Injection 85 mg/m^2 | Participants received irinotecan liposome injection 85 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| BG001 | Part 1: Irinotecan Liposome Injection 70 mg/m^2 | Participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| BG002 | Part 2: Irinotecan Liposome Injection 70 mg/m^2 | Eligible participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| BG003 | Part 2: Topotecan 1.5 mg/m^2 | Eligible participants received topotecan 1.5 mg/m^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
| BG004 | 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, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| 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 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant following or during exposure to a study treatment, whether or not causally related to the study treatment. An undesirable medical condition could be symptoms, signs or abnormal results of an investigation. An SAE was any AE that: resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; resulted in congenital anomaly or birth defect; or was medically important. A TEAE was any AE that occurred or worsened on or after the day of first dose of study treatment and within 30 days after discontinuation of study treatment. | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Posted | Count of Participants | Participants | No | The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Dose-Limiting Toxicities (DLT) | A TEAE was considered as DLT if it occurred during the safety evaluation period (i.e. first 28 days of treatment or 14 days after the second dose of study treatment if there was a treatment delay due to non-DLT related reasons) and were deemed related to the study treatment by the investigator. The determination of whether an Adverse Event was considered a Dose Limiting Toxicity was made by the Safety Review Committee (SRC) comprising the Part 1 Investigators and the Medical Monitor(s) of the Sponsor. | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Posted | Count of Participants | Participants | No | From the start of the first study treatment administration (Day 1) up to 14 days after the second dose of study treatment administration, a maximum of 42 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | Part 2: Overall Survival (OS) | The OS was defined as the time from randomization date to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status. | Part 2: The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | From date of randomization (within 7 days before start of study treatment) until death. Assessed up to Part 2 primary analysis DCO date of 08 February 2022 (approximately 900 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Objective Response Rate (ORR) | The ORR was defined as the percentage of participants with a best overall response (BOR) characterized as either a complete response (CR) or partial response (PR) recorded from date of first dose of study treatment until documented PD or death. ORR analysis was based on BOR using RECIST v1.1 per investigator assessment. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had computed tomography (CT)-scans and brain magnetic resonance imaging (MRI) every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Progression-Free Survival (PFS) | The PFS was defined as time from first dose of study treatment to the first documented objective PD using RECIST v1.1 or death due to any cause, whichever occurs first. Per RECIST 1.1, progression is defined as at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Posted | Median | 95% Confidence Interval | months | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 1177 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: OS | The OS was defined as the time from first dose of study treatment to the date of death from any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. The OS was calculated using Kaplan-Meier technique. Following end of treatment participant and/or family was contacted by telephone every month to assess vital status. | Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. | Posted | Median | 95% Confidence Interval | months | From Baseline (Day 1) until death. Assessed up to Part 1 DCO date of 11 August 2021 (approximately 1177 days) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: PFS | The PFS was defined as time from randomization to first documented objective PD using RECIST 1.1 (or response assessment in neuro-oncology brain metastases [RANO-BM] criteria for central nervous system [CNS] lesions) as assessed by blinded independent central review (BICR) or death due to any cause, whichever occurred first. Per RECIST 1.1, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The PFS was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. | Posted | Median | 95% Confidence Interval | months | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: ORR | The ORR was defined as percentage of participants with a BOR characterized as either a CR or PR, recorded from randomization until documented PD or death relative to the total number of participants. ORR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesions; and overall response = CR + PR. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Median Duration of Response (DoR) | The DoR was defined as time from the first documented objective response (CR or PR, whichever was earlier) to the date of first documented PD or death due to any cause. The DoR analysis was based on BOR assessed by BICR using RECIST v1.1. Per RECIST v1.1, CR is disappearance of all target lesions and PR is >=30% decrease in the sum of the longest diameter of target lesions. The DoR was calculated using Kaplan-Meier technique. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Median Time to Objective Response (OR) | Time to OR as per RECIST v1.1 criteria according to BICR was defined as time from the date of randomization to the date of first documented objective tumor response (CR or PR, whichever was first). Per RECIST v1.1, CR is disappearance of all target lesions; PR is >=30% decrease in the sum of the longest diameter of target lesion. Participants with a new anti-cancer therapy prior to OR were censored at the last tumor assessment prior to new anti-cancer therapy. Per protocol, participants had CT-scans and brain MRI every 6 weeks to measure tumor lesion size. This was continued throughout treatment until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. Only participants with objective response were analyzed. | Posted | Median | 95% Confidence Interval | months | RECIST assessments performed at Baseline (within 28 days before start of study treatment), every 6 weeks post first dose and treatment pause, 30 days after discontinuation of study treatment, then every month thereafter, approximately maximum of 900 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)/Lung Cancer Supplement (LC13) Dyspnea Scale at Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Scores range from 0-100 and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in dyspnea scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 1) and Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EORTC QLQ-LC13 Cough Scale at Week 12 | The EORTC QLQ-LC13 is a lung cancer specific module used in conjunction with EORTC QLQ-C30 and covers typical symptoms of lung cancer (cough, pain, dyspnea, sore mouth, peripheral neuropathy, hair loss). Score ranges from 0-100 scale and a high score represents a high level of symptomatology/problems/worse QoL. Baseline was defined as the last non-missing measurement taken prior to reference start date. Change from baseline in cough scale was calculated regardless of premature study treatment discontinuation. Participants completed these questionnaires on an electronic tablet every 6 weeks during treatment and it was continued until PD or commencement of new anti-neoplastic therapy. | Part 2: The ITT population included all randomized participants. Only participants analyzed at Week 12 are reported. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (Day 1) and Week 12 |
|
The TEAEs were reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration, approximately 680 days for Part 1 and 1452 days for Part 2. All-Cause Mortality: approximately 1919 days
Part 1: Safety population included all enrolled participants who were treated with at least 1 dose of irinotecan liposome injection. Part 2: Safety population included all randomized participants who were treated with at least 1 dose of study treatment. AEs are coded using MedDRA version 26.0. During all study visits, participants were asked to report any adverse events/symptoms since prior study visit.
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 | Part 1: Irinotecan Liposome Injection 85 mg/m^2 | Participants received irinotecan liposome injection 85 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 5 | 5 | 4 | 5 | 5 | 5 |
| EG001 | Part 1: Irinotecan Liposome Injection 70 mg/m^2 | Participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 23 | 25 | 9 | 25 | 25 | 25 |
| EG002 | Part 2: Irinotecan Liposome Injection 70 mg/m^2 | Eligible participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes, every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 201 | 226 | 106 | 226 | 212 | 226 |
| EG003 | Part 2: Topotecan 1.5 mg/m^2 | Eligible participants received topotecan 1.5 mg/m^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. | 205 | 223 | 88 | 223 | 220 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Ectopic antidiuretic hormone secretion | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Narcotic bowel syndrome | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Embolism arterial | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Death | General disorders | 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Complication associated with device | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 26.0 | Systematic Assessment |
| |
| Pain | General disorders | 26.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 26.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 26.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Exposure to SARS-CoV-2 | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Vertebrobasilar stroke | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Aortic thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | 26.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.0 | Systematic Assessment |
| |
| Pain | General disorders | 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Bioscience, Inc. | see email | clinical.trials@ipsen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2021 | Aug 17, 2023 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| C584112 | irinotecan sucrosofate |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Investigator decision |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Screen failure |
|
| Other |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Reported |
|
| Not Hispanic or Latino |
|
| Not Reported/Unknown |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
Participants received irinotecan liposome injection 70 mg/m^2 i.v. over 90 minutes every 2 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Eligible participants received topotecan 1.5 mg/m^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|
|
|
|
|
|
|
Eligible participants received topotecan 1.5 mg/m^2 i.v. over 30 minutes daily for 5 consecutive days, every 3 weeks in a 6-week cycle until PD, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|
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