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RECRUITING
NCT06174987
PHASE3

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

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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).

Official title: A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-01-05

Completion Date

2028-01-17

Last Updated

2025-10-15

Healthy Volunteers

No

Interventions

DRUG

T-DXd

T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Locations (28)

Miami Cancer Institute

Miami, Florida, United States

Duke University - Trent Center

Durham, North Carolina, United States

Flinders Medical Center

Bedford Park, Australia

Monash Medical Center

Melbourne, Australia

Grand Hôpital de Charleroi

Charleroi, 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, France

Rabin Medical Center

Petah Tikva, Israel

Ospedale San Raffaele

Milan, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

National Cancer Center Hospital

Chūō, Japan

Kyungpook National University Chilgok Hospital

Daegu, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Seoul National University Hospital

Jongno-gu, South Korea

Severance Hospital, Yonsei University

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitari Dexeus

Distrito de Les Corts, Spain

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Spain

Hospital Ruber Internacional

Madrid, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Royal Surrey County Hospital

Guildford, United Kingdom