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

RECRUITINGPhase 3Sponsored by Daiichi Sankyo
Actively Recruiting
PhasePhase 3
SponsorDaiichi Sankyo
Started2024-01-05
Est. completion2026-08-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Advanced CancerCancerMetastatic Cancer

Locations2 sites

Florida

1 site
Miami Cancer Institute
Miami, Florida, 33176

North Carolina

1 site
Duke University - Trent Center
Durham, North Carolina, 27710

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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