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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513870-23 | Other Identifier | European Medicines Agency |
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The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | Experimental | Participants will receive 10 mg/kg of SG intravenously (IV) on Day 1 and Day 8 of each 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met. |
|
| Treatment of Physician's Choice | Active Comparator | Participants will receive 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and will continue to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion is met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle (in countries where vinflunine was approved and was commercially available). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis. | Up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) by Investigator Assessment | PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). KM estimates were used for analysis. |
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Key Inclusion Criteria:
Individuals with histologically documented metastatic or locally advanced unresectable UC defined as
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
Individuals with progression or recurrence following receipt of platinum-containing regimen and anti programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1) therapy for metastatic or locally advanced unresectable disease will be enrolled.
Individuals with recurrence or progression ≤12 months following completion of cisplatin-containing chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These individuals must receive anti PD-1/PD-L1 therapy in the metastatic or locally advanced unresectable setting to be eligible.
Individuals who received either carboplatin or anti PD-1/PD-L1 therapy in the neo- adjuvant/adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
Cisplatin ineligible individuals who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility. They must then have received anti PD-1/PD-L1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study.
-- Cisplatin ineligibility is defined as meeting one of the following criteria:
Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
Individuals who have progressed after receiving enfortumab vedotin in prior lines of therapy, and individuals who are either ineligible or unable to tolerate enfortumab vedotin therapy, are eligible to enroll in the study
Individuals who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.
Individuals with previously treated brain metastases may participate in the study provided they have stable central nervous system disease for at least 4 weeks prior to the first dose of study drug and stabilization of all neurologic symptoms, have no evidence of new or enlarging brain metastases, and are not using steroids >20 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to first dose of the study drug.
Adequate hematologic counts without transfusion or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥1,500/mm^3, and platelets ≥100,000/µL).
Adequate hepatic function (bilirubin ≤1.5x institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin >3 g/dL).
Docetaxel will only be option in TPC arm for individuals with a total bilirubin ≤1 x IULN, and an AST and/or ALT ≤1.5x IULN if alkaline phosphatase is also >2.5 x IULN.
Key Exclusion Criteria:
Females who are pregnant or lactating.
Have had a prior anti-cancer monoclonal antibody (mAb)/ antibody-drug conjugate (ADC) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Individuals participating in observational studies are eligible.
Have received prior chemotherapy for UC with any available standard of care (SOC) therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is approved and is commercially available).
Have not recovered (i.e., ≤ Grade 1) from adverse events due to previously administered chemotherapeutic agent.
Note: Individuals with ≤ Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.
Note: If Individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.
Have previously received topoisomerase 1 inhibitors.
Have an active second malignancy.
Note: Individuals with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll in the study after discussion with the medical monitor.
Have active cardiac disease, defined as:
Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of enrollment.
Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
Have known history of Human Immunodeficiency Virus (HIV)-1/2 with undetectable viral load and on medications that may interfere with SN-38 metabolism.
Have active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). In individuals with a history of HBV or HCV, individuals with a detectable viral load will be excluded.
Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan-hziy or unable or unwilling to receive the doses specified in the protocol.
Have inability to complete all specified study procedures for any reason.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Arizona | Phoenix | Arizona | 85054 | United States | ||
| UCLA Hematology/ Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39934055 | Background | Powles T, Tagawa S, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Loriot Y, Grivas P. Sacituzumab govitecan in advanced urothelial carcinoma: TROPiCS-04, a phase III randomized trial. Ann Oncol. 2025 May;36(5):561-571. doi: 10.1016/j.annonc.2025.01.011. Epub 2025 Feb 11. | |
| Background | Grivas P, Tagawa S, Bellmunt J, De Santis M, Duran I, Goebell PJ, et al. TROPiCS-04: Study of Sacituzumab Govitecan in Metastatic or Locally Advanced Unresectable Urothelial Cancer That Has Progressed After Platinum and Checkpoint Inhibitor Therapy. [Poster TPS498]. American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU); 2021 February 11-13; Virtual meeting. | ||
| Background | Grivas P., Powles T., Vulsteke C., Gross-Goupil M., Park S. et al. LBA9 TROPiCS-04, a randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (CT) in pretreated advanced urothelial carcinoma (aUC): Overall survival (OS) and safety analysis. Annals of Oncology, Volume 35, Supplement 4, S1505-S1507, December 2024. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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886 participants were screened.
Participants were enrolled at study sites in Asia, Australia, Europe, and North America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacituzumab Govitecan-hziy (SG) | Participants received SG 10 mg/kg intravenously (IV) on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months). |
| FG001 | Treatment of Physician's Choice |
| 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 | Aug 30, 2024 | Apr 2, 2026 |
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| Paclitaxel | Drug | Administered intravenously |
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| Docetaxel | Drug | Administered intravenously |
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| Vinflunine | Drug | Administered intravenously |
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| Up to 42 months |
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) | PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first. PD was defined in outcome measure (OM) #2. KM estimates were used for analysis. | Up to 42 months |
| Objective Response Rate (ORR) by Investigator Assessment | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment. CR was defined as disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Percentages were rounded off. | Up to 42 months |
| Objective Response Rate (ORR) by BICR | ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR. CR and PR are defined in OM#4. Percentages were rounded off. | Up to 42 months |
| Clinical Benefit Rate (CBR) by Investigator Assessment | CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4. Percentages were rounded off. | Up to 42 months |
| Clinical Benefit Rate (CBR) by BICR | CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR. PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6. Percentages were rounded off. | Up to 42 months |
| Duration of Objective Tumor Response (DOR) by Investigator Assessment | DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4. | Up to 42 months |
| Duration of Objective Tumor Response (DOR) by BICR | DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4. | Up to 42 months |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off. | From first dose up to 33.6 months |
| Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities | A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days. Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death. Percentages were rounded off. | From first dose up to 33.6 months |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life. | Baseline (Day 0) |
| Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life. | Cycle 5 Day 1; Cycle length = 21 days |
| Los Angeles |
| California |
| 90095 |
| United States |
| University of California Irvine (UCIMC) | Orange | California | 92868 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Boca Raton Clinical Research Global USA - Plantation | Plantation | Florida | 33322 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oklahoma Cancer Specialists and Research Institute (OCSRI) | Tulsa | Oklahoma | 74104 | United States |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| Thompson Oncology Group - Knoxville Downtown | Knoxville | Tennessee | 37916 | United States |
| University Cancer Specialists - Knoxville | Knoxville | Tennessee | 37920 | United States |
| Harold C. Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Seattle Cancer Care Alliance (SCCA) | Seattle | Washington | 98109 | United States |
| Summit Cancer Centers | Spokane | Washington | 99208 | United States |
| Chris O'Brien Lifehouse | North Ryde | New South Wales | 2109 | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Icon Cancer Centre Wesley | Auchenflower | Queensland | 4066 | Australia |
| Southern Adelaide Local Health Network Incorporated | Bedford Park | South Australia | 5042 | Australia |
| Ashford Cancer Centre Research - ICON Cancer Centre Adelaide | Kurralta Park | South Australia | 5037 | Australia |
| ICON Cancer Centre Hobart | Hobart | Tasmania | 7001 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sunshine Hospital | Saint Albans | Victoria | 3021 | Australia |
| Liverpool Hospital | Nedlands | Western Australia | 6009 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Universitätsklinik für Innere Medizin Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz GmbH Barmherzige Schwestern | Linz | 4010 | Austria |
| Krankenhaus Der Barmherzigen Bruder Wien | Vienna | 1020 | Austria |
| Grand Hôpital De Charleroi - Notre Dame | Charleroi | 6000 | Belgium |
| Az Maria Middelares Ghent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | B-4000 | Belgium |
| Multiprofile Hospital for Active Treatment Heart and Brain EAD | Pleven | 5800 | Bulgaria |
| Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District | Sofia | 1233 | Bulgaria |
| Cross Cancer Institute | Edmonton | T6G 1Z2 | Canada |
| qeii health sciences centre - VG site | Halifax | B3H 2Y9 | Canada |
| Juravinski Hospital and Cancer Centre | Hamilton | L8V 5C2 | Canada |
| London Health Sciences Centre | London | N6A 4G5 | Canada |
| Jewish General Hospital | Montreal | H3T 1E2 | Canada |
| McGill University Health Centre | Montreal | H4A 3J1 | Canada |
| R.S. McLaughlin Durham Regional Cancer Centre | Oshawa | L1G 2B9 | Canada |
| Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| British Columbia Cancer Agency-Vancouver Centre | Vancouver | V5Z 4E6 | Canada |
| Peking University First Hospital | Beijing | 100034 | China |
| Chinese People's Liberation Army General Hospital - 301 Hospital | Beijing | 100039 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Chinese Academy of Medical Sciences Cancer Hospital | Beijing | 100730 | China |
| 1st Hospital Jilin University | Changchun | 130021 | China |
| Hunan Cancer Hospital - Xiangya Hospital - Central South University | Changsha | 410013 | China |
| West China Hospital Sichuan University | Chengdu | 610041 | China |
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu | 610072 | China |
| Chongqing University Cancer Hospital | Chongqing | 400030 | China |
| The First Affiliated Hospital of Fujian Medical University | Fujian | 350005 | China |
| Union Hospital of Fujian Medical University | Fuzhou | 350001 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | 510060 | China |
| Zhejiang Provincial People's Hospital - Zhaohui | Hangzhou | 310014 | China |
| Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Anhui Provincial Cancer Hospital | Hefei | 230031 | China |
| Qilu Hospital of Shandong University | Jinan | 250012 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | 330006 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | 110042 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | 300060 | China |
| Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | 830000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | 325000 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430030 | China |
| Clinical Hospital Centre Split | Split | 21000 | Croatia |
| Clinical Hospital Centre "Sestre Milosrdnice" | Zagreb | 10000 | Croatia |
| University Hospital Centre Zagreb | Zagreb | Croatia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Urocentrum Praha | Prague | 120 00 | Czechia |
| Ramsay Health Clinic Belharra | Bayonne | France |
| CHU Saint Andre | Bordeaux | 33075 | France |
| Centre Hospiltalier Universitaire Brest - Hôpital Morvan | Brest | 29200 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre Georges- Francois Leclerc | Dijon | 21000 | France |
| Centre Hospitalier Departemental Vendee | La Roche-sur-Yon | 85925 CEDEX 9 | France |
| Centre Oscar Lambret | Lille | 59000 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut Régional du Cancer de Montpellier ICM Val d' Aurelle | Montpellier | 34090 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Centre Hospitalier Universitaire de Nimes | Nîmes | 30029 | France |
| Hôpital Européen Georges-Pompidou | Paris | 75015 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Hospitalier Privé Saint-Grégoire | Saint-Grégoire | 35760 | France |
| Les Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| High Technology Hospital MedCenter | Batumi | 6000 | Georgia |
| New Hospitals | Tbilisi | 0114 | Georgia |
| L. Managadze National Center of Urology | Tbilisi | 0144 | Georgia |
| Evex Medical corporation | Tbilisi | 0160 | Georgia |
| Jerarsi Clinic | Tbilisi | 0167 | Georgia |
| Universitatsklinik Dresden | Dresden | 01307 | Germany |
| Malteser Waldkrankenhaus Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Centrum fur Hamatologie und Onkologie Bethanien | Frankfurt am Main | 60389 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Institut Für Versorgungsforschung in Der Onkologie | Koblenz | 56068 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Studienpraxis Urologie | Nürtingen | 72622 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Charité Universitätsmedizin Berlin - Campus Benjamin Franklin | Wien | 1100 | Germany |
| 401 General Military Hospital of Athens | Athens | 115 25 | Greece |
| Henry Dunant Hospital | Athens | 115 26 | Greece |
| Alexandra General Hospital | Athens | 11528 | Greece |
| Attikon Hospital | Chaïdári | 124 62 | Greece |
| Regional University General Hospital of Herakleio, Crete | Herakleio | 81352 | Greece |
| University Hospital Of Ioannina | Ioannina | 45332 | Greece |
| University Hospital of Larissa | Larissa | 413 34 | Greece |
| Athens Medical Center | Marousi | 151 25 | Greece |
| University Hospital of Patras | Pátrai | 26332 | Greece |
| Bioclinic - Thessaloniki | Thessaloniki | 546 22 | Greece |
| Theagenio Anticancer Hospital of Thessaloniki | Thessaloniki | 546 39 | Greece |
| Anassa General Clinic | Thessaloniki | 54623 | Greece |
| Interbalkan Medical Center of Thessaloniki | Thessaloniki | 555 35 | Greece |
| Prince of Wales Hospital | Hong Kong | 0 | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Hong Kong United Oncology Centre | Kowloon | Hong Kong |
| Tallaght University Hospital | Dublin | D24 NR0A | Ireland |
| University Hospital Waterford | Waterford | X91 ER8E | Ireland |
| Shamir Medical Center (Assaf Harofeh) | Be’er Ya‘aqov | 7030000 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah University Hospital Ein Kerem | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Tel Aviv Medical Center (Ichilov Hospital) | Tel Aviv | 6423906 | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Ospedale San Donato | Arezzo | 52100 | Italy |
| Centro di Riferimento Oncologico di Aviano | Aviano | 33081 | Italy |
| Istituto Tumori Bari Giovanni Paolo II - IRCCS | Bari | 70124 | Italy |
| Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia | Candiolo (TO) | 10060 | Italy |
| Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola | 47014 | Italy |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Azienda Ospedaliero Universitaria Maggiore Della Carita | Novara | 28100 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | 56126 | Italy |
| Istituto Regina Elena | Roma | 00144 | Italy |
| Università Campus Bio-Medico di Roma | Rome | 00128 | Italy |
| Ospedale Civile Di Sondrio | Sondrio | 23100 | Italy |
| Azienda Ospedaliera Santa Maria di Terni | Terni | 05100 | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Torino | 10043 | Italy |
| Ospedale di Trento - Presidio Ospedaliero Santa Chiara | Trento | 38122 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona | Verona | 37126 | Italy |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Unidade Local de Saúde da Guarda - Hospital Sousa Martins | Guarda | 6300-858 | Portugal |
| Centro Hospitalar de Leiria - Hospital de Santo André | Leiria | 2410-197 | Portugal |
| Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E | Porto | Portugal |
| Centro Hospitalar de Tras-os-Montes e Alto Douro | Vila Real | 5000 | Portugal |
| BRCR Medical Center, Inc | San Juan | PR | 00907 | Puerto Rico |
| National University Hospital | Singapore | 119074 | Singapore |
| Icon Cancer Centre Farrer Park | Singapore | 217562 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | 361-711 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul Saint Mary's Hospital | Seoul | 137-040 | South Korea |
| The Catholic University of Korea Saint Vincent's Hospital | Suwon | 16247 | South Korea |
| Hospital del Mar - Parc de Salut | Barcelona | 08003 | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital Reina Sofia | Córdoba | 14004 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Clínica Universidad de Navarra - Madrid | Madrid | 28027 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Sant Joan de Déu de Manresa | Manresa | 08243 | Spain |
| Complexo Hospitalario de Ourense (CHOU) | Ourense | 32005 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Álvaro Cunqueiro Hospital | Vigo | 36213 | Spain |
| Länssjukhuset Ryhov | Jönköping | 553 05 | Sweden |
| Universitetssjukhuset i Linköping | Linköping | 581 85 | Sweden |
| Karolinska Universitetssjukhuset - Solna | Stockholm | 171 76 | Sweden |
| University Hospital Basel | Basel | 4051 | Switzerland |
| Istituto Oncologico Della Svizzera Italiana (IOSI) | Bellinzona | 6500 | Switzerland |
| University of Bern | Bern | 3010 | Switzerland |
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
| Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie | Zurich | 8091 | Switzerland |
| Chiayi Chang Gung Memorial Hospital | Buzi | 613 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833 | Taiwan |
| Taipei Tzu Chi General Hospital | New Taipei City | 231405 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan 407 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital - Linkou Branch | Taoyuan | 333 | Taiwan |
| Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu | Ankara | 6230 | Turkey (Türkiye) |
| Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi | Edirne | 22030 | Turkey (Türkiye) |
| Bagcilar Medipol Mega Universite Hastanesi | Istanbul | 34214 | Turkey (Türkiye) |
| Istanbul Acibadem University Maslak Hospital | Istanbul | 34457 | Turkey (Türkiye) |
| T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi | Istanbul | 34722 | Turkey (Türkiye) |
| Medical Park Izmır Hastanesi | Izmir | 35575 | Turkey (Türkiye) |
| Cebeci Hastanesi | Mamak | 6620 | Turkey (Türkiye) |
| VKV Amerikan Hastanesi Department of Oncology | Şişli | 34365 | Turkey (Türkiye) |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2WB | United Kingdom |
| Dorset County Hospital NHS Foundation Trust | Dorchester | DT1 2JY | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G12 0YN | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital | London | SE1 9RT | United Kingdom |
| Sarah Cannon Research Institute London | London | W1G 6AD | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| East and North Hertfordshire NHS Trust | Middlesex | HA6 2RN | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| Swansea Bay University Health Board | Port Talbot | SA12 7BR | United Kingdom |
| Royal Preston Hospital | Preston | PR2 9HT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Surrey | SM2 5PT | United Kingdom |
| The Royal Wolverhampton NHS Trust | Wolverhampton | WV10 0QP | United Kingdom |
| Background | Vulsteke C, Grivas P, Tagawa ST, Bellmunt J, De Santis M, Duran I, et al. TROPiCS-04: Study of Sacituzumab Govitecan (SG) in Patients (Pts) With Locally Advanced (LA) Unresectable or M etastatic Urothelial Cancer (mUC) That Has Progressed After Prior Platinum (PLT) and Checkpoint Inhibitor (CPI) Therapy. [Poster TPS582]. American Society of Clinical Oncology Genitourinary (ASCO-GU); 2022 February 17-19; Annual Meeting. |
| 41277126 | Derived | Powles T, Tagawa ST, Vulsteke C, Gross-Goupil M, Park SH, Necchi A, De Santis M, Duran I, Morales-Barrera R, Guo J, Sternberg CN, Bellmunt J, Goebell PJ, Kovalenko M, Boateng F, Sierecki M, Wang L, Sima CS, Waldes J, Bangs R, Loriot Y, Grivas P. A plain language summary of the TROPiCS-04 study: sacituzumab govitecan use after platinum-based chemotherapy and immunotherapy in people with locally advanced or metastatic cancer of the bladder, urethra, or upper urinary tract. Future Oncol. 2025 Dec;21(28):3593-3610. doi: 10.1080/14796694.2025.2579003. Epub 2025 Nov 23. |
| 39472646 | Derived | Klumper N, Cox A, Sjodahl G, Roghmann F, Bolenz C, Hartmann A, Grunwald V, Faltas BM, Holzel M, Eckstein M. Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. Nat Rev Urol. 2025 May;22(5):256-267. doi: 10.1038/s41585-024-00951-2. Epub 2024 Oct 29. |
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available). |
| COMPLETED |
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| NOT COMPLETED |
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The Intent-to-treat (ITT) Analysis Set included all participants who have been randomized to the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sacituzumab Govitecan-hziy (SG) | Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months). |
| BG001 | Treatment of Physician's Choice | Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available). |
| 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, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||||
| Region of Enrollment | 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 | Overall Survival (OS) | OS was defined as time from the date of randomization to the date of death, regardless of cause. Kaplan-Meier (KM) estimates were used for analysis. | Participants in the Intent-to-treat (ITT) Analysis Set were analyzed. The ITT Analysis Set included all participants who have been randomized to the trial. | Posted | Median | 95% Confidence Interval | months | Up to 42 months |
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| Secondary | Progression-Free Survival (PFS) by Investigator Assessment | PFS was defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per response evaluation criteria in solid tumors (RECIST) v1.1 criteria as determined by investigator assessment, or death regardless of cause, whichever occurs first. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). KM estimates were used for analysis. | Participants in the ITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42 months |
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| Secondary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) | PFS is defined as the time from the date of randomization to the date of the first objectively documented disease progression (PD), per RECIST v1.1 criteria as determined by BICR, or death regardless of cause, whichever occurs first. PD was defined in outcome measure (OM) #2. KM estimates were used for analysis. | Participants in the ITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42 months |
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| Secondary | Objective Response Rate (ORR) by Investigator Assessment | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) as best overall response (BOR) as assessed by investigator assessment. CR was defined as disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Percentages were rounded off. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42 months |
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| Secondary | Objective Response Rate (ORR) by BICR | ORR was defined as the percentage of participants who achieved a CR or PR as BOR as assessed by BICR. CR and PR are defined in OM#4. Percentages were rounded off. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42 months |
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| Secondary | Clinical Benefit Rate (CBR) by Investigator Assessment | CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or stable disease (SD) for ≥ 6 months, per RECIST v1.1, as assessed by investigator assessment. SD is defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started; PD was defined in OM#2; BOR, CR and PR are defined in OM#4. Percentages were rounded off. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42 months |
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| Secondary | Clinical Benefit Rate (CBR) by BICR | CBR was defined as the percentage of participants who achieved a BOR of confirmed CR, PR, or SD for ≥ 6 months, per RECIST v1.1, as assessed by BICR. PD was defined in OM#2; BOR, CR and PR are defined in OM#4; SD was defined in OM#6. Percentages were rounded off. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42 months |
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| Secondary | Duration of Objective Tumor Response (DOR) by Investigator Assessment | DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by investigator assessment, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4. | Participants in the ITT Analysis Set with Confirmed CR or PR per Investigator assessment were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42 months |
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| Secondary | Duration of Objective Tumor Response (DOR) by BICR | DOR was defined as the time from the date when the criteria is first met for a CR or PR to the first date that PD is documented per RECIST 1.1 as determined by BICR, or date of death, whichever occurs first. KM estimates were used in analysis. PD was defined in OM#2, CR and PR are defined in OM#4. | Participants in the ITT Analysis Set with Confirmed CR or PR per BICR assessment were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 42 months |
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| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. The SAE was defined as any untoward medical occurrence that at any dose which was fatal (results in death) or life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or an important medical event. TEAEs were defined as an AE that onset in the period from the first dose of study treatment to 30 days after the last dose of study treatment. Percentages were rounded off. | Participants in the Safety Analysis Set were analyzed. Safety Analysis Set included all participants who were administered with at least 1 dose of SG or Treatment of Physician's Choice. | Posted | Number | percentage of participants | From first dose up to 33.6 months |
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| Secondary | Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities | A laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time of postbaseline up to and including the date of last study drug dose plus 30 days. Severity grades were defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death. Percentages were rounded off. | Participants in the Safety Analysis Set with at least 1 post-baseline value were analyzed. | Posted | Number | percentage of participants | From first dose up to 33.6 months |
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| Secondary | European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life. | Participants in the Health-Related Quality of Life (HRQoL) Evaluable Analysis Set were analyzed. HRQoL Evaluable Analysis Set was defined as participants in the ITT Analysis Set who had an evaluable assessment of the EORTC QLQ-C30 at baseline and at least 1 evaluable assessment at postbaseline visits. | Posted | Mean | Standard Deviation | score on scale | Baseline (Day 0) |
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| Secondary | Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (EORTC-QLQ-C30) Domain Score | The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer participants, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Domain scores were reported for following scales: Physical Functioning, Global Health Status, Pain, and Fatigue Score. Scoring of the QLQ-C30 was performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant). For Symptom scales, a lower score means better quality of life. For Global Health Status and Functional Scales, a higher score signifies better quality of life. | Participants in the HRQoL Evaluable Analysis Set with available data were analyzed. HRQoL Evaluable Analysis Set was defined as participants in the ITT Analysis Set who had an evaluable assessment of the EORTC QLQ-C30 at baseline and at least 1 evaluable assessment at postbaseline visits. | Posted | Least Squares Mean | 95% Confidence Interval | score on scale | Cycle 5 Day 1; Cycle length = 21 days |
|
Up to 42 months
All-Cause Mortality: The Intent-to-Treat Analysis Set consisted of all participants who have been randomized to the trial.
Adverse Events: Safety Analysis Set consisted of all participants who administered at least 1 dose of Sacituzumab govitecan-hziy or Treatment of Physician's Choice.
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 | Sacituzumab Govitecan-hziy (SG) | Participants received SG 10 mg/kg IV on Days 1 and 8 of every 21-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met (up to 33 months). | 305 | 355 | 185 | 349 | 341 | 349 |
| EG001 | Treatment of Physician's Choice | Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available). | 310 | 356 | 110 | 337 | 303 | 337 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death, not otherwise specified | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infected urinoma | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Klebsiella urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Psoas abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Stoma prolapse | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Escherichia test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Sars-cov-2 test positive | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 28.0 | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema genital | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Penile haemorrhage | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| May-Thurner syndrome | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral vein thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2023 | Apr 2, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| C111217 | vinflunine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other or More Than One Race |
|
| Not Collected |
|
| Hispanic or Latino |
|
| Not Collected |
|
| Spain |
|
| China |
|
| South Korea |
|
| United Kingdom |
|
| Italy |
|
| Belgium |
|
| Greece |
|
| Australia |
|
| Germany |
|
| Canada |
|
| Austria |
|
| Taiwan |
|
| United States |
|
| Georgia |
|
| Israel |
|
| Portugal |
|
| Singapore |
|
| Sweden |
|
| Ireland |
|
| Bulgaria |
|
| Croatia |
|
| Switzerland |
|
| Turkey |
|
| Hong Kong |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met.
Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available).
|
|
|
|
| OG001 | Treatment of Physician's Choice | Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available). |
|
|
| OG001 | Treatment of Physician's Choice | Participants received 1 of 3 standard-of-care chemotherapeutic options, as determined by the investigator prior to randomization, and continued to receive the same treatment for the duration of the study until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met. Paclitaxel 175 mg/m^2 IV on Day 1 of every 21-day cycle up to 27 months or Docetaxel 75 mg/m^2 IV on Day 1 of every 21-day cycle up to 30 months or Vinflunine 320 mg/m^2 IV on Day 1 of every 21-day cycle up to 29 months (in countries where vinflunine was approved and was commercially available). |
|
|
|