A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
NCT ID: NCT06174987
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2024-01-05
2028-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T-DXd
Participants who choose to continue treatment with T-DXd may be enrolled. Participants who were on the comparator arm in the parent study will be provided the option to access the drug through standard of care (SoC) or other available options.
Participants will remain on their current dosage regimen of T-DXd as the last dose administered in the parent study, unless they experience an AE that requires dose reduction at the EOT of the parent study, in which case the starting dose in this study will be the next lower dose-level.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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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
Napoli, , 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 City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Royal Surrey County Hospital
Guildford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-506330-73-00
Identifier Type: OTHER
Identifier Source: secondary_id
ROMast-001
Identifier Type: -
Identifier Source: org_study_id
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