Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
QuANTUM-WILD
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia
2 other identifiers
interventional
700
26 countries
278
Brief Summary
This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 leukemia
Started Nov 2024
278 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
November 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 26, 2030
July 2, 2026
June 1, 2026
5.6 years
August 14, 2024
June 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (Arm A vs Arm B)
Overall survival (OS) is defined as the time from randomization until death from any cause.
Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Secondary Outcomes (6)
Event-free survival (Arm A vs. Arm B)
Date of randomization up to approximately 42 months
Duration of complete response (Arm A vs. Arm B)
Date of randomization up to approximately 42 months
Relapse-free survival (Arm A vs. Arm B)
Date of randomization up to approximately 42 months
Complete remission rate (Arm A vs. Arm B)
At end of Induction Phase, up to approximately 120 days
Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)
At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days
- +1 more secondary outcomes
Study Arms (3)
Arm A: Quizartinib + Chemotherapy
EXPERIMENTALParticipants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Arm B: Placebo + Chemotherapy
PLACEBO COMPARATORParticipants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
EXPERIMENTALParticipants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Interventions
Participants will receive quizartinib at 60 mg/day orally once daily
Participants will receive placebo at 60 mg/day orally once daily
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Eligibility Criteria
You may qualify if:
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
- ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
- Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
- Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
- Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment
You may not qualify if:
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
- Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
- Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
- Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD \[+\]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
- Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Cranial radiotherapy for central nervous system (CNS) leukostasis;
- Prophylactic intrathecal chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (284)
City of Hope Phoenix
Goodyear, Arizona, 85338, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
David Geffen School of Medicine
Los Angeles, California, 90095, United States
University of California Davis Health System
Sacramento, California, 95817, United States
Ucsf Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Stanford University School of Medicine- Parent
Stanford, California, 94305, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Yale University
New Haven, Connecticut, 06510, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Mayo Clinic Hospital
Jacksonville, Florida, 32224, United States
Florida Hospital Cancer Institute - Kissimmee
Kissimmee, Florida, 34741, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
Robert H Lurie Comprehensive Cancer Center Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Kentucky
Lexington, Kentucky, 40504, United States
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine
Ann Arbor, Michigan, 48109, United States
University of Minnesota Medical School - Twin Cities Campus
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Thomas Jefferson Univ Hosp
Haddonfield, New Jersey, 08033, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center - Main
Long Island City, New York, 11101, United States
Memorial Sloan Kettering Cancer Center - Main
New York, New York, 10065, United States
Upstate University Hospital
Syracuse, New York, 13210, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514, United States
Duke Cancer Institute - Sarcoma Research
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Peggy & Charles Stephenson Oklahoma Cancer Ctr
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University (Ohsu)
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Tristar Bone Marrow Transplant
Nashville, Tennessee, 37203, United States
South Austin Medical Center
Austin, Texas, 78745, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
Uva Health System
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University (Vcu) Massey Cancer Center
Richmond, Virginia, 23229, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Royal Adelaide Hospital
Adelaide, 5000, Australia
Flinders Medical Centre (Fmc)
Bedford Park, 5042, Australia
Flinders Medical Centre (Fmc)
Bedford Park, Australia
Box Hill Hospital
Box Hill, 3128, Australia
Concord Repatriation General Hospital
Concord, 2139, Australia
St Vincent'S Hospital Melbourne
Darlinghurst, 2010, Australia
Townsville University Hospital
Douglas, 4814, Australia
Liverpool Hospital
Liverpool, 2170, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Sir Charles Gairdner Hospital
Perth, 6009, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Ordensklinikum Linz Gmbh - Elisabethinen
Linz, 4020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Hanusch Krankenhaus Der Wgkk Wien
Vienna, 1140, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
ZNA
Antwerp, 2060, Belgium
Az Sint-Jan
Bruges, 8000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Uz Leuven
Leuven, 3000, Belgium
Chu de Liage
Liège, 4000, Belgium
AZ DELTA
Roeselare, 8800, Belgium
Cetus Hospital Dia Oncologia
Belo Horizonte, Brazil
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
Botucatu, 18618-686, Brazil
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
Campinas, 13083-878, Brazil
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, 81520-060, Brazil
Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina
Florianópolis, Brazil
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, 60430-370, Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, 74680160, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210-120, Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, 99010-260, Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074, Brazil
Hospital de Clănicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
INCA - Instituto Nacional de Cancer
Rio de Janeiro, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto, 15090-000, Brazil
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
Hospital Beneficencia Portuguesa da Sao Paulo
São Paulo, 01323-001, Brazil
Hospital Nove de Julho
São Paulo, 01409902, Brazil
Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
São Paulo, Brazil
Umhat 'Dr. Georgi Stranski', Ead
Pleven, 5800, Bulgaria
Umhat 'Sv. Georgi', Ead
Plovdiv, 4002, Bulgaria
Umhat Âsv. Ivan Rilskiâ, Ead
Sofia, 1431, Bulgaria
Military Medical Academy - Mhat - Sofia
Sofia, 1606, Bulgaria
'Shathd' Ead Sofia
Sofia, 1797, Bulgaria
Umhat Prof. Dr. Stoyan Kirkovich Ad
Stara Zagora, 6000, Bulgaria
London Health Sciences Centre
London, N6A 5W9, Canada
McGill University - Dept. Oncology Clinical Research Program
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6, Canada
Saskatoon Cancer Centre
Saskatoon, S7N 4H4, Canada
Princess Margaret Cancer Center
Toronto, M5G 2M9, Canada
Peking University First Hospital
Beijing, 100034, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital
Beijing, 100730, China
The First Hospital of Jilin University
Changchun, 130021, China
Xiangya Hospital, Central South University
Changsha, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Sun Yat-Sen University, Cancer Center
Guangzhou, 510060/510700, China
Guangdong Provincial People'S Hospital
Guangzhou, 510080, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Zhong Da Hospital, Southeast University
Nanjing, 210009, China
Affiliated Hospital of Nantong University
Nantong, 226001, China
The Affiliated Hospital of Qingdao University
Qingdao, 266071, China
Shanghai Tongren Hospital
Shanghai, 200050, China
Shengjing Hospital of China Medical University
Shengyang, 110004, China
Shenzhen Second People'S Hospital
Shenzhen, 518029, China
The Second Hospital of Hebei Medicical University
Shijiazhuang, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, 300020, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325015, China
Wuxi People'S Hospital
Wuxi, 214023, China
The First Affiliated Hospital of Xiâan Jiaotong University
Xi'an, 710061, China
Yantai Yuhuangding Hospital
Yantai, 264000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hospital Centar Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Fakultni Nemocnice Brno
Brno, 625 00, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 50005, Czechia
Fakultni Nemocnice Plzen
Pilsen, 304 60, Czechia
Fakultni Nemocnice Ostrava
Poruba, 708 52, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Ustav Hematologie A Krevni Transfuze
Prague, 12800, Czechia
Chu Angers - Hăpital Hătel Dieu
Angers, 49033, France
Chu de Caen
Caen, 14033, France
Chu de Grenoble - Hospital Albert Michallon
La Tronche, 38700, France
Centre Hospitalier de Versailles
Le Chesnay, 78150, France
Hopital Claude Huriez - Chru Lille
Lille, 59037, France
Centre Léon Bérard
Lyon, 69008, France
Hopital de La Conception - Aphm
Marseille, 13005, France
Chu de Nantes - Hotel Dieu
Nantes, 44093, France
CHU Nice - Hôpital de l'Archet 1
Nice, 06200, France
Hospital Saint-Louis
Paris, 75475, France
Chu de Bordeaux - Hăpital Haut-Lăvăque
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre BĂŠnite, 69495, France
Chu Rennes - Hopital Pontchaillou
Rennes, 35000, France
Chu Amiens - Hopital Sud
Salouël, 80480, France
Institut de Cancérologie de Strasbourg Europe - ICANS
Strasbourg, 67200, France
Institut de Cancărologie de Strasbourg Europe - Icans
Strasbourg, 67200, France
Institut Universitaire Du Cancer de Toulouse- Iuct-O
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, France
Klinikum Aschaffenburg-Alzenau
Alzenau in Unterfranken, 63755, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Staedtisches Klinikum Braunschweig Ggmbh
Braunschweig, 38114, Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Krh Klinikum Siloah
Hanover, 30459, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol
Leipzig, 4103, Germany
Universitaetsklinikum Muenster
Münster, Germany
The University of Hong Kong
Hong Kong, Hong Kong
The Chinese University of Hong Kong (Cuhk)
Shatin, 00000, Hong Kong
Semmelweis Egyetem
Budapest, 1088, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
Bari, 70124, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Brescia, 25100, Italy
Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
Meldola, 47014, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, 20162, Italy
Ospedale Maggiore Di Novara
Novara, Italy
Azienda Ospedaliera Vincenzo Cervello
Palermo, 90146, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, 168, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, 133, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Irccs Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino
Torino, 10126, Italy
Ospedale Mauriziano Umberto I
Torino, 10128, Italy
Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
Varese, 21100, Italy
Akita University Hospital
Akita, 010-8543, Japan
Aomori Prefetural Central Hospital
Aomori, 030-8553, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō City, 113-8677, Japan
Chiba Aoba Municipal Hospital
Chiba, 260-0852, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Chugoku Central Hospital
Fukuyama, Japan
Gifu Municipal Hospital
Gifu, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, 431-3192, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi, 296-8602, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Japan
Saiseikai Maebashi Hospital
Maebashi, Japan
Ehime Prefectural Central Hospital
Matsuyama, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Osaka Red Cross Hospital
Osakar, 543-8555, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Sapporo Hokuyu Hospital
Sapporo, Japan
Tenri Hospital
Tenri, 632-8552, Japan
Haukeland Universitetssykehus
Bergen, N-5021, Norway
Oslo University Hospital Rikshospitalet Clinical Research Unit
Oslo, Norway
University Hospital of North Norway
Tromsø, 9019, Norway
Klinika Hematoonkologii I Transplantacji Szpiku
Lublin, 20-081, Poland
Instytut Hematologii I Transfuzjologii
Warsaw, 02-776, Poland
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Instituto Portugues De Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Clinic Coltea
Bucharest, 030171, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-Napoca, 400015, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Military Medical Academy
Belgrade, 11000, Serbia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
National University Hospital
Singapore, 119228, Singapore
Curie Oncology Pte Ltd
Singapore, 329563, Singapore
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Daegu Catholic University Medical Center
Daegu, 42472, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary'S Hospital
Seoul, 06591, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Asan Medical Center
Seoul, 5505, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Complejo Hospitalario Universitario de Albacete
Albacete, 02006, Spain
Hospital General Universitario Doctor Balmis
Alicante, 03010, Spain
Ico Badalona - Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 8025, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Universitario De Burgos
Burgos, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Md Anderson Cancer Centre
Madrid, 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28220, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Hospital Universitari Son Espases
Palma de Mallorca, 07120, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39012, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41010, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset
Gasteborg, 41345, Sweden
Skă Nes Universitetssjukhus, Lund
Lund, 22185, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Inselspital - Universitaetsspital Bern
Bern, 3010, Switzerland
Luzerner Kantonsspital - Luzern
Lazern 16, Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 404327, Taiwan
National Cheng Kung University Hospitalx
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital
Taoyuan County, 00333, Taiwan
Queen Elizabeth Hospital
Birmingham, United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
King'S College Hospital
London, SE5 9NU, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Torbay Hospital
Torquay, TQ2 7AA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- This study has a double-blind design. Neither the participants nor any of the investigators, Sponsor, Independent Review Committee (IRC) or contract research organizations (CROs) will be aware of the treatments received. An independent biostatistician, not otherwise part of the Sponsor trial team, will generate the randomization schedule.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2024
First Posted
August 29, 2024
Study Start
November 19, 2024
Primary Completion (Estimated)
June 26, 2030
Study Completion (Estimated)
June 26, 2030
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/