A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Daiichi Sankyo
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).
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 under the Rollover Study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 \>…
Interventions
- DrugT-DXd
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)
- Miami Cancer InstituteMiami, Florida
- Duke University - Trent CenterDurham, North Carolina
- Flinders Medical CenterBedford Park
- Monash Medical CenterMelbourne
- Grand Hôpital de CharleroiCharleroi
- Instituto AericasRio de Janeiro