A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Daiichi Sankyo
50 participants
Jan 5, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria3
- 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 Criteria2
- 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
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06174987