Status:
RECRUITING
A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
AstraZeneca
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 D...
Detailed Description
This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 17 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06174987
Start Date
January 5 2024
End Date
January 17 2028
Last Update
October 15 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Miami Cancer Institute
Miami, Florida, United States, 33176
2
Duke University - Trent Center
Durham, North Carolina, United States, 27710
3
Flinders Medical Center
Bedford Park, Australia, 5042
4
Monash Medical Center
Melbourne, Australia, 3168