|
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
View on ClinicalTrials.gov →
NCT06174987
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 siteMiami Cancer Institute
Miami, Florida, 33176
North Carolina
1 siteDuke University - Trent Center
Durham, North Carolina, 27710
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 3
SponsorDaiichi Sankyo
Started2024-01-05
Est. completion2026-08-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06174987