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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928406
Other study ID # MO29983
Secondary ID 2016-002625-11
Status Completed
Phase Phase 3
First received
Last updated
Start date November 30, 2016
Est. completion date December 12, 2022

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.


Recruitment information / eligibility

Status Completed
Enrollment 1004
Est. completion date December 12, 2022
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract - Participants with measurable and/or non-measurable disease according to RECIST v1.1 - Participants must have progressed during or following treatment with at least one prior (and not more than 3) treatments for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract - If available, a representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block should be submitted - Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: - Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation 1. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were not on active drug in that prior trial are eligible 2. Participants who were in another clinical trial with therapeutic intent within 4 weeks of study treatment initiation but were in the follow-up phase of that prior trial and had stopped receiving active drug 4 or more weeks before study treatment initiation are eligible - Malignancies other than the one studied in this protocol within 5 years prior to Cycle 1, Day 1 - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol - Significant renal disorder indicating a need for renal transplant

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab
Atezolizumab 1200 milligrams (mg) will be administered by intravenous (IV) infusion Q3W.

Locations

Country Name City State
Argentina Inst. Alexander Fleming; Oncologia Buenos Aires
Argentina Hospital Aleman Caba
Argentina Hospital Britanico de Buenos Aires Ciudad Autonoma Buenos Aires
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia Canberra Hospital; Medical Oncology Canberra Australian Capital Territory
Australia Austin Hospital Olivia Newton John Cancer Centre Heidelberg Victoria
Australia Royal Hobart Hospital; Hematology/Oncology Hobart Tasmania
Australia Macquarie University Hospital Macquarie Park New South Wales
Australia Prince of Wales Hospital; Oncology Randwick New South Wales
Australia Icon Cancer Foundation South Brisbane Queensland
Australia Northern Cancer Institute St Leonards New South Wales
Australia Calvary Mater Newcastle; Medical Oncology Waratah New South Wales
Austria Medizinische Universität Innsbruck; Universitätsklinik für Urologie Innsbruck
Austria Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie Linz
Austria Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU Salzburg
Austria Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie Wien
Austria Medizinische Universität Wien; Universitätsklinik für Urologie Wien
Belgium UZ Brussel Brussel
Belgium Cliniques Universitaires St-Luc Bruxelles
Belgium UZ Leuven Gasthuisberg Leuven
Belgium CHU Sart-Tilman Liège
Brazil Hospital de Cancer de Barretos Barretos SP
Brazil Centro Integrado de Oncologia de Curitiba Curitiba PR
Brazil Pronutrir - suporte nutricional e quimioterapia ltda. Fortaleza CE
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital Alemao Oswaldo Cruz Sao Paulo SP
Brazil Hospital Sírio-Libanês Sao Paulo SP
Bulgaria Complex Oncology Center (COC)-Plovidiv Plovdiv
Bulgaria SHATOD - Sofia Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Sofia
Canada Royal Victoria Hospital Barrie Ontario
Canada Tom Baker Cancer Centre-Calgary Calgary Alberta
Canada Cross Cancer Institute ; Dept of Medical Oncology Edmonton Alberta
Canada Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia
Canada The Ottawa Hospital Cancer Center; General Campus Ottawa Ontario
China Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing City
Colombia Clinica del Country Bogota
Croatia Clinical Hospital Centre Zagreb Zagreb
Czechia Fakultni nemocnice u sv. Anny v Brne Brno
Czechia Fakultni nemocnice Kralovske Vinohrady Praha
Czechia Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni Praha
Denmark Aalborg Universitetshospital; Onkologisk Afdeling Aalborg
Denmark Aarhus Universitetshospital; Kræftafdelingen Aarhus N
Denmark Herlev Hospital; Afdeling for Kræftbehandling Herlev
Denmark Rigshospitalet; Onkologisk Klinik København Ø
Estonia East Tallinn Central Hospital; Clinic of Internal Medicine Tallinn
Estonia North Estonia Medical Centre Foundation; Oncology Center Tallinn
Germany Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie Dresden
Germany Universitätsklinikum Erlangen; Medizinische Klinik 5 - Hämatound Internist Onko Erlangen
Germany Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie Göttingen
Germany Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie Halle (Saale)
Germany Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie Hannover
Germany Onkologische Schwerpunktpraxis Heidelberg
Germany Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Urologie Lübeck
Germany Kliniken Maria Hilf GmbH, Krankenhaus St. Franziskus Mönchengladbach
Germany Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik München
Germany Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie Münster
Germany Universitätsklinikum Tübingen; Klinik für Urologie Tübingen
Germany Universitätsklinikum Ulm; Klinik für Urologie Ulm
Greece Alexandras General Hospital of Athens; Oncology Department Athens
Greece IASO General Hospital of Athens Athens
Greece Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept. Kifisia
Greece Metropolitan Hospital; 2Nd Oncology Clinic Piraeus
Greece Thermi Clinic; Oncology Clinic Thermi Thessalonikis
Greece Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki
Greece Papageorgiou General Hospital; Medical Oncology Thessaloniki
Hungary Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department Budapest
Hungary Orszagos Onkologiai Intezet Budapest
Hungary Semmelwies University of Medicine; Urology Dept. Budapest
Hungary Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika Szeged
Hungary Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály Szolnok
India HealthCare Global Cancer Centre; Medical Oncology Ahmedabad Gujarat
India Artemis Health Institute Gurgaon Haryana
India TATA Medical Centre; Medical Oncology Kolkata WEST Bengal
India Max Super Speciality Hospital New Delhi Delhi
Ireland Cork University Hospital Cork
Ireland Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit Dublin
Italy Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia Arezzo Toscana
Italy Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica Bari Puglia
Italy Asst Papa Giovanni XXIII; Oncologia Medica Bergamo Lombardia
Italy AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica Bologna Emilia-Romagna
Italy A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia Cagliari Sardegna
Italy Ospedale Cannizzaro, Oncologia Catania Sicilia
Italy Policlinico Ospedaliero Ss Annunziata; U.O. Di Clinica Oncologica Chieti Abruzzo
Italy ASST DI CREMONA; Dip. Medicina - S.C. Oncologia Cremona Lombardia
Italy IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A Genova Liguria
Italy IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica Meldola Emilia-Romagna
Italy Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 Milano Lombardia
Italy Istituto Europeo Di Oncologia Milano Lombardia
Italy A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna
Italy Azienda Ospedaliera Universitaria Federico II Napoli Campania
Italy ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico Napoli Campania
Italy A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica Orbassano Piemonte
Italy IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima Padova Veneto
Italy Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 Pisa Toscana
Italy Arcispedale Santa Maria Nuova; Oncologia Reggio Emilia Emilia-Romagna
Italy Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica Roma Lazio
Italy Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica Roma Lazio
Italy Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica Roma Lazio
Italy IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia San Giovanni Rotondo Puglia
Italy Azienda Ospedaliera S. Maria - Terni; Oncologia Terni Umbria
Italy A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia Udine Friuli-Venezia Giulia
Italy Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Oncologia Medica Verona Veneto
Lebanon Hotel Dieu de France; Oncology Beirut
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Endocrinology clinic Kaunas
Lithuania National Cancer Institute Vilnius
Netherlands NKI/AvL Amsterdam
Netherlands VU MEDISCH CENTRUM; Dept. of Medical Oncology Amsterdam
Netherlands Academ Ziekenhuis Groningen; Medical Oncology Groningen
Netherlands Maastricht University Medical Centre; Medical Oncology Maastricht
Netherlands St. Antonius locatie Leidsche Rijn Utrecht
Poland NZOZ Onko-Dent G. L. Slomian, Spolka Jawna ?ory
Poland Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii Lublin
Poland Szpital Kliniczny Przemienienia Pa?skiego Uniwersytetu Medycznego im. Karola Marcinkowskiego Poznan
Poland Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o. Warszawa
Portugal Hospital de Braga; Servico de Oncologia Medica X Braga
Portugal HUC; Servico de Urologia e Transplantacao Renal Coimbra
Portugal Hospital de Santa Maria; Servico de Oncologia Medica Lisboa
Portugal IPO do Porto; Servico de Oncologia Medica Porto
Romania Oncopremium Team Srl Baia Mare
Romania Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Spital de zi-Parter Cluj-Napoca
Romania Centrul de Oncologie Sfantul Nectarie Craiova
Romania Centrul de Radioterapie AMETHYST Floresti
Romania Oncomed SRL; Oncologie Timisoara
Russian Federation Blokhin Cancer Research Center; Urological Dept Moscow Moskovskaja Oblast
Russian Federation P.A. Herzen Oncological Inst. ; Oncology Moscow Moskovskaja Oblast
Saudi Arabia King Faisal Specialist Hospital & Research Centre; Oncology Riyadh
Slovakia Narodny onkologicky ustav Bratislava
Spain Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Badalona Barcelona
Spain Hospital Clínic i Provincial; Servicio de Oncología Barcelona
Spain Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia Barcelona
Spain Hospital del Mar Barcelona Barcelona
Spain Hospital Duran i Reynals; Oncologia Barcelona
Spain Hospital de Basurto; Servicio de Oncologia Bilbao Vizcaya
Spain Hospital San Pedro De Alcantara; Servicio de Oncologia Caceres
Spain Hospital Universitario Reina Sofia; Servicio de Oncologia Córdoba Cordoba
Spain Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia Girona
Spain Hospital General Universitario de Guadalajara; Servicio de Oncologia Guadalajara
Spain Hospital Universitario de Canarias;servicio de Oncologia La Laguna Tenerife
Spain Hospital Lucus Augusti; Servicio de Oncologia Lugo
Spain Hospital Clinico San Carlos; Servicio de Oncologia Madrid
Spain HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid
Spain Hospital Ramon y Cajal; Servicio de Oncologia Madrid
Spain Hospital Universitario 12 de Octubre; Servicio de Oncologia Madrid
Spain Hospital Universitario La Paz; Servicio de Oncologia Madrid
Spain Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Malaga
Spain Complejo Hospitalario de Althaia; Servicio de Oncologia Manresa Barcelona
Spain Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia Murcia
Spain Hospital de Navarra; Servicio de Oncologia Navarra
Spain Complejo Hospitalario de Orense; Servicio de Oncologia Orense
Spain Hospital Univ. Central de Asturias; Servicio de Oncologia Oviedo Asturias
Spain Hospital Universitario Son Espases; Servicio de Oncologia Palma De Mallorca Islas Baleares
Spain Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona
Spain Hospital Univ Vall d'Hebron; Servicio de Oncologia Sant Andreu de La Barca Barcelona
Spain Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña
Spain Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla
Spain Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia Toledo
Spain Hospital Clínico Universitario de Valencia; Servicio de Oncología Valencia
Spain Hospital General Universitario de Valencia; Servicio de oncologia Valencia
Spain Hospital La Fe Valencia
Switzerland Universitaetsspital Basel; Onkologie Basel
Switzerland Ospedale Regionale di Bellinzona Medizin Onkologie Bellinzona
Switzerland Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit Bern
Switzerland Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie Chur
Switzerland Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie Geneve
Switzerland Luzerner Kantonsspital; Medizinische Onkologie Luzern
Switzerland Kantonsspital Winterthur; Medizinische Onkologie Winterthur
Taiwan National Cheng Kung Uni Hospital; Dept of Hematology and Oncology Tainan
Taiwan Chang Gung Medical Foundation-Linkou, Urinary Oncology Taoyuan
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom Raigmore Hospital; Dept of Radiotherapy & Oncology Inverness
United Kingdom Leicester Royal Infirmary NHS Trust Leicester
United Kingdom Barts and the London NHS Trust. London
United Kingdom Royal Marsden NHS Foundation Trust Sutton

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  Germany,  Greece,  Hungary,  India,  Ireland,  Italy,  Lebanon,  Lithuania,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Slovakia,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Adverse Events (AEs) AEs were defined as any untoward medical occurrence in a subject administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. New disease, exacerbation of existing disease, recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test associated with symptoms or leading to a change in study/concomitant treatment or discontinuation from study drug as well as events related to protocol-mandated interventions are considered AEs. Baseline up to end of study (up to approximately 6 years)
Secondary Overall Survival (OS) OS was defined as date of death (due to any cause) or censoring minus date of start of study treatment plus 1. Randomization until death from any cause (up to approximately 6 years)
Secondary Progression Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) PFS was defined as the date of first occurrence of tumor progression (earliest of the dates of the RECIST component indicating tumor progression) or date of death (in the absence of tumor progression) by any cause, whichever occurred first, or date of censoring minus date of start of study treatment plus 1. Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary PFS as Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) PFS as per Modified RECIST was defined as:
date of first occurrence of tumor progression after a modified confirmed response if the participant was a responder according to modified RECIST or
date of first occurrence of tumor progression in case the participant was not a responder according to modified RECIST or
date of death (in the absence of tumor progression) by any cause, or
date of censoring whichever occurred first, minus date of start of study treatment plus 1
Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Percentage of Participants With Best Overall Response (BOR) as Assessed by RECIST v1.1 BOR was assessed by the investigators according to the RECIST v1.1. BOR was defined as a complete response (CR) or partial response (PR) determined on two consecutive investigator assessments >= 4 weeks apart in participants with measurable disease at baseline. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeters (mm); PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Percentage of Participants With BOR as Assessed by Modified RECIST BOR was assessed by the investigators according to the modified RECIST. BOR was defined as complete response (CR) or partial response (PR). CR includes complete disappearance of all tumor lesions and no new measurable or unmeasurable lesions confirmed by a consecutive assessment >=4 weeks from the first documented date. PR is a decrease in the sum of the diameters of all target and all new measurable lesions >=30%, relative to baseline, in the absence of CR confirmed by a consecutive assessment >=4 weeks from the first documented date. The assessment of BOR included post-screening RECIST assessments obtained up to: 1) death from any cause, 2) last evaluable RECIST assessment in the absence of death, 3) start of a subsequent anti-cancer therapy, whichever occurred first. Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Percentage of Participants With Disease Control as Assessed by RECIST v1.1 Disease control was determined separately on disease status using RECIST v1.1 by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates. Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Percentage of Participants With Disease Control as Assessed by Modified RECIST Disease control was determined separately on disease status using modified RECIST by the investigator. Disease control rate was defined as the sum of the complete response, partial response, and stable disease rates. Randomization up to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Duration of Response (DOR) as Assessed by RECIST v1.1 Duration of response was determined separately on disease status using RECIST v1.1 by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression or death from any cause, or to censoring date: 1) end of response coincided with the date of tumor progression or death (in the absence of tumor progression) used for the PFS endpoint, 2) for a participant without disease progression or death following a response, the censored end of response coincided with the PFS censoring date (that was latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first). Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary DOR as Assessed by Modified RECIST Duration of response was determined separately on disease status using modified RECIST by the investigator. For overall responders, DoR was defined as the time from the date of first occurrence of a confirmed response (complete response or partial response) to date of tumor progression following that confirmed response or death from any cause, or to censoring date: 1) end of response was the date of tumor progression after that confirmed response or death (in the absence of tumor progression), 2) for a participant without disease progression or death following a response, the censored end of response was the latest RECIST assessment or start of subsequent cancer therapy, whichever occurred first. Time from first occurrence of a documented response to disease progression or death from any cause, whichever occurred first (up to approximately 6 years)
Secondary Change From Baseline in Health-Related Quality of Life (HRQoL), as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale. Higher scores on the global health status and functional scales indicated better health status/function. Higher scores on the symptoms scales and symptom items indicated greater symptom burden. Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days)
Secondary Change From Baseline in European Quality of Life (EuroQoL) Group 5-Dimension 5-Level (EQ-5D-5L) Self Report Questionnaire Health Utility Score The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) is a self-report health status questionnaire that consists of 6 questions used to calculate a health utility score for use in health economic analysis. There are two components to the EuroQol EQ-5D: 1) five health dimensions that assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; 2) a visual analogue scale (VAS) that measures health state. There are 5 response levels for each dimension (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems) with the highest level representing the worst outcome. The VAS is scored on a scale from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health. Baseline, Day 1 of Cycles 1, 2, 3 and thereafter every 9 weeks for 54 weeks from study treatment start; and then every 12 weeks until progression/study discontinuation (up to approximately 6 years) (Cycle length = 21 days)
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