A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Recruiting now · Phase 3
Conditions studied: Advanced Cancer, Metastatic Cancer
In brief
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).
Key facts
- Study ID
- NCT06174987
- Run by
- Daiichi Sankyo
- People needed
- 50
- Starts
- 2024-01-05
- Expected to finish
- 2028-01-17
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Miami Cancer Institute — Miami, Florida, United States (enrolling)
- Duke University - Trent Center — Durham, North Carolina, United States (enrolling)
- Grand Hôpital de Charleroi — Charleroi, Belgium (enrolling)
- Institut Gustave Roussy — Villejuif, France (enrolling)
- Ospedale San Raffaele — Milan, Italy (enrolling)
- National Cancer Center Hospital — Chūō, Japan (enrolling)
- Kyungpook National University Chilgok Hospital — Daegu, South Korea (enrolling)
- National Cancer Center — Gyeonggi-do, South Korea (enrolling)
- Seoul National University Hospital — Jongno-gu, South Korea (enrolling)
- Severance Hospital, Yonsei University — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Complejo Hospitalario Universitario A Coruña — A Coruña, Spain (enrolling)
- Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
- ICO l'Hospitalet - Hospital Duran i Reynals — L'Hospitalet de Llobregat, Spain (enrolling)
- Flinders Medical Center — Bedford Park, Australia
- Monash Medical Center — Melbourne, Australia
- Seoul National University Bundang Hospital — Gyeonggi-do, South Korea
- Instituto Aericas — Rio de Janeiro, Brazil
- A.C. Camargo Cancer Center — São Paulo, Brazil
- IBCC Nucleo de Pequisa e Ensino — São Paulo, Brazil
- National Taiwan University Hospital — Taipei, Taiwan
- Rabin Medical Center — Petah Tikva, Israel
- Hospital Universitari Dexeus — Distrito de Les Corts, Spain
- Istituto Nazionale Tumori Fondazione G. Pascale — Naples, Italy
Full record on ClinicalTrials.gov
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