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NCT06174987PHASE3Recruiting

A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Daiichi Sankyo

Start Date

1/5/2024

Completion Date

1/17/2028

Summary

This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101, DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).

Detailed Description

This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements. * Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition. * No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s). Exclusion Criteria: * Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria * Participant who has been off T-DXd therapy for \>18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study

Interventions

DRUG

T-DXd

Interested in This Trial?

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Conditions

Advanced CancerMetastatic Cancer

Locations

Miami Cancer Institute

Miami, Florida 33176

United States

Duke University - Trent Center

Durham, North Carolina 27710

United States

Flinders Medical Center

Bedford Park, 5042

Australia

Monash Medical Center

Melbourne, 3168

Australia

Grand Hôpital de Charleroi

Charleroi, 6000

Belgium

Instituto Aericas

Rio de Janeiro,

Brazil

A.C. Camargo Cancer Center

São Paulo,

Brazil

IBCC Nucleo de Pequisa e Ensino

São Paulo,

Brazil

Institut Gustave Roussy

Villejuif, 94805

France

Rabin Medical Center

Petah Tikva,

Israel

Ospedale San Raffaele

Milan, 20132

Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, 80131

Italy

National Cancer Center Hospital

Chūō, 104-0045

Japan

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

National Cancer Center

Gyeonggi-do, 10408

South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, 13620

South Korea

Seoul National University Hospital

Jongno-gu, 03080

South Korea

Severance Hospital, Yonsei University

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitari Dexeus

Distrito de Les Corts, 08028

Spain

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 08908

Spain

Hospital Ruber Internacional

Madrid, 28034

Spain

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Royal Surrey County Hospital

Guildford, GU2 7XX

United Kingdom