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

NCT06174987

RecruitingPhase 3

Sponsor: Daiichi Sankyo

Conditions: Advanced Cancer, Metastatic Cancer

Interventions: T-DXd

Countries: United States, Australia, Belgium, Brazil, France, Israel, Italy, Japan

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (28)
  • Miami, Florida, United States
  • Durham, North Carolina, United States
  • Bedford Park, Australia
  • Melbourne, Australia
  • Charleroi, Belgium
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Villejuif, France
  • Petah Tikva, Israel
  • Milan, Italy
  • Naples, Italy
  • Chūō, Japan
  • Daegu, South Korea
  • Gyeonggi-do, South Korea
  • Gyeonggi-do, South Korea
  • Jongno-gu, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • A Coruña, Spain
  • Barcelona, Spain
  • Distrito de Les Corts, Spain
  • L'Hospitalet de Llobregat, Spain
  • Madrid, Spain
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Guildford, United Kingdom