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A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
RecruitingPhase 3
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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).
What is being tested
- T-DXd (drug)
Sponsor: Daiichi Sankyo · Participants: 50 · Started: Jan 5, 2024
Contact the study team
- Daiichi Sankyo Contact for Clinical Trial Information · Phone: 908-992-6400
Official record on ClinicalTrials.gov — NCT06174987
Locations in the U.S.
| Florida | Miami Cancer Institute, Miami |
| North Carolina | Duke University - Trent Center, Durham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.